Efficacy and Safety of Desmopressin Melt for the Treatment of Nocturia

Condition(s) targeted: Nocturia

Intervention: Desmopressin Melt (Drug); desmopressin acetate (Minirin® Melt) (Drug); desmopressin acetate (Minirin® Melt) (Drug); desmopressin acetate (Minirin® Melt) (Drug); desmopressin acetate (Minirin® Melt) (Drug); desmopressin acetate (Minirin® Melt) (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Ferring Pharmaceuticals

Official(s) and/or principal investigator(s):
Brad Shumel, MD, Study Director, Affiliation: Ferring Pharmaceutical Inc.

Overall contact:
Kim Duffy, Phone: 973-797-8802, Email: kim@dspclinical.com

The purpose of this study is to investigate the efficacy and safety of several doses of the melt formulation of desmopressin in a broad population of adult patients with nocturia.

Official title: A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multi-Center Study With a Double Blind Extension Investigating the Efficacy and Safety of a Fast- Dissolving ("Melt") Formulation of Desmopressin for the Treatment of Nocturia in Adults

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 1) Change in mean number of nocturnal voids 2) Proportion of subjects with > 33% reduction from baseline in mean number of voids.

Secondary outcome: 1) Change in total sleep time 2) Quality of life 3) Treatment safety.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria

1. Written informed consent prior to the performance of any study-related activity.

2. Patients 18 years and older with an average of ≥ 2 nocturnal voids per night as determined by a 3 day voiding diary

Exclusion Criteria:

Males:

1. Clinical suspicion of bladder outlet obstruction and/or urine flow < 5 ml/s. If medical history and/or physical examination suggest bladder outlet obstruction, uroflowmetry should be performed to confirm the diagnosis

2. Surgical treatment for bladder outlet obstruction/benign prostatic hyperplasia performed within the past 6 months

Females:

3. Pregnancy. Females of reproductive age must have documentation of a reliable method of contraception.

4. Use of pessary for pelvic prolapse

5. Unexplained pelvic mass

Males and Females:

6. Clinical suspicion of urinary retention and/or post void residual volume > 150 ml. If medical history and/or physical examination suggest urinary retention, post void bladder ultrasound or catheterization should be performed to confirm the diagnosis

7. Current or past urologic malignancy (e. g. bladder cancer, prostate cancer, etc.)

8. Clinical evidence of current genito-urinary tract pathology (e. g. infection, stone, tumor, etc.)

9. Neurogenic detrusor activity (previously known as detrusor hyperreflexia)

10. Suspicion or evidence of cardiac failure

11. Uncontrolled hypertension

12. Uncontrolled diabetes mellitus

13. Renal insufficiency. Serum creatinine must be within normal limits.

14. Active hepatic and/or biliary disease. AST or ALT should not be >2 times the upper limit of normal. Total bilirubin should not be > 1. 5 mg/dL.

15. Hyponatremia. Serum sodium level must be within normal limits

16. Syndrome of Inappropriate ADH secretion

17. Diabetes insipidus (urine output > 40 ml/kg over 24 hours) as determined by the 3 day voiding diary

18. Psychogenic or habitual polydipsia

19. Obstructive sleep apnea

20. Hyperkinetic limb disorders (e. g. restless leg syndrome) known to impair sleep Other

21. Known alcohol or substance abuse

22. Work or lifestyle potentially interfering with regular night-time sleep (e. g. shift workers)

23. Previous desmopressin treatment for nocturia

24. Psychiatric condition, mental incapacity or language barrier which, in the judgment of the investigator, would impair patient participation in the trial

Concomitant Medications

The following medications are permitted provided that the subject has been on a stable dose for the 3 months prior to the screening date (i. e. treatment has not been initiated or discontinued and there has been no change in dose):

- Alpha-blockers: Cardura (doxazosin); Flomax (tamsulosin); Hytrin (terazosin);

Uroxatral (alfuzosin)

- 5 alpha-reductase inhibitors: Avodart (dutaseride); Proscar (finasteride)

- Antispasmodic, anticholinergic, antimuscarinic therapy for overactive bladder: Detrol,

Detrol LA (tolterodine); Ditropan, Ditropan XL (oxybutynin); Enablex (darifenacin); Levsin(hyoscyamine); Oxytrol transdermal (oxybutynin); Sanctura (trospium); Vesicare (solifenacin)

- Sedative/hypnotic medications for sleep disorders

- Selective serotonin and mixed norepinephrine/serotonin reuptake inhibitors: Celexa

(citalopram); Cymbalta (duloxetine); Effexor (venlafaxine); Lexapro (escitalopram); Paxil(paroxetine); Prozac (fluoxetine); Zoloft (sertraline)

- Chronic use of non-steroidal anti-inflammatory agents

- Diabinese (chlorpropamide)

- Carbamazepine (carbatrol/tegretol)

- Amiodarone

The following medications are excluded:

- Diuretics

- Any other investigational drug within 30 days of screening

Kim Duffy, Phone: 973-797-8802, Email: kim@dspclinical.com

Radiant Research, Birmingham, Alabama 35209, United States; Recruiting
Kendra Metcalf, Phone: 205-870-8803
Gordon Connor, MD, Principal Investigator

Radiant Research, Scottsdale, Arizona 85251, United States; Recruiting
Sue Frederick, Phone: 480-946-4455
F. McCarty III, MD, Principal Investigator

Arkansas Primary Care Clinic, Little Rock, Arkansas 72204, United States; Recruiting
Cecile Madden, Phone: 501-661-0531, Email: cmadden@researchsolutionscorp.com
Derek Lewis, MD, Principal Investigator

Southern Interior Medical Center, Kelowna, British Columbia V1Y-2H4, Canada; Recruiting
Joe Husch, Phone: 250-764-1949, Email: jhusch.simr@telus.net
Thomas Kinahan, MD, Principal Investigator

Can-Med Clinical Research Inc., Victoria, British Columbia V8T 5G1, Canada; Recruiting
Renza Brown, Phone: 250-370-2606, Email: renza@can-med.ca
Peter Pommerville, Principal Investigator

Dr. Steinhoff Clinical Research, Victoria, British Columbia V8V 3N1, Canada; Recruiting
Catherine Douglas, Phone: 250-388-0840, Email: catherine@gsteinhoff.com
Gary Steinhoff, MD, Principal Investigator

California Professional Research, Newport Beach, California 92660, United States; Recruiting
Sandi Bunting, Phone: 949-644-7214, Email: sandi@research.occoxmail.com
Stephen Auerback, MD, Principal Investigator

West Coast Clinical Research, Tarzana, California 91356, United States; Recruiting
Brenda Fulham, Phone: 818-776-0820, Email: bfulham@wccresearch.com
Eugene Dula, Principal Investigator

Impact Clinical Trials, Beverly Hills, California 90211, United States; Recruiting
Lindsey Nigro, Phone: 310-289-8242
Lydie Hazan, MD, Principal Investigator

Radiant Research, Santa Rosa, California 95404, United States; Recruiting
Andrew McCoy, Phone: 707-542-1469, Email: AndyMcCoy@radiantresearch.com
Robert James, Principal Investigator

San Diego Uro-Research, San Diego, California 92103, United States; Recruiting
Patti Sanchez-Emery, Phone: 619-299-6500, Email: patti@sdur.com
William Moseley, MD, Principal Investigator

Advanced Urology Medical Center, Anaheim, California 92801, United States; Recruiting
Vera Martinez, Phone: 714-776-2030, Email: advancedurotrial@aol.com
Alfred Sidhom, MD, Principal Investigator

Atlantic Urology Medical Group, Long Beach, California 90806, United States; Recruiting
Sulu Mose, Phone: 562-595-9011, Email: slmose_aumg319@yahoo.com
Barton Wachs, MD, Principal Investigator

Western Clinical Research, Torrance, California 90505, United States; Recruiting
Carolyn Ferguson, Phone: 310-378-5003, Email: fergie@latrials.com
Norman Zinner, MD, Principal Investigator

Urology Associates PC, Denver, Colorado 80210, United States; Recruiting
Suzanne Bogosian, Phone: 303-733-8848, Ext: 1262, Email: s.bogosian@uradenver.com
Barrett Cowan, Principal Investigator

Genitourinary Surgical Consultants, Denver, Colorado 80220, United States; Recruiting
Isabel Arnold, Phone: 303-320-0120, Email: isabelarnold@msn.com
Jeffrey Snyder, MD, Principal Investigator

Downtown Women's Health Care, Denver, Colorado 80218, United States; Recruiting
Kelly Servin, Phone: 303-298-0222
Arthur Waldbaum, MD, Principal Investigator

Connecticut Clinical Research Center, LLC, Middlebury, Connecticut 06762, United States; Recruiting
Jacklen Cable, Phone: 203-754-3588, Ext: 351, Email: jcableccrcuro@aim.com
Joseph Antoci, MD, Principal Investigator

Radiant Research, West Palm Beach, Florida 33407, United States; Recruiting
Denise Alvarado, Phone: 561-845-1030, Email: denisealvarado@radiantresearch.com
Hal Bashein, MD, Principal Investigator

Radiant Research, Stuart, Florida 34996, United States; Recruiting
Marilou Valdez, Phone: 772-781-3000, Email: marylouvaldez@radiantresearch.com
Darrell Fiske, MD, Principal Investigator

South Florida Medical Research, Aventura, Florida 33180, United States; Recruiting
Sayonara Nunez, Phone: 305-931-8080, Email: SNunez@southfloridamedicalresearch.com
Marc Gittelman, Principal Investigator

Sunrise Medical Research, Plantation, Florida 33324, United States; Recruiting
Ellen Amigo, Phone: 954-915-9991, Email: medicalresearch@att.net
Marshall Kaplan, Principal Investigator

Southeastern Research Group, Inc., Tallahassee, Florida 32308, United States; Recruiting
Stacey Nelson, Phone: 850-201-0411, Ext: 471, Email: rschm@seuc.com
Scott Sellinger, MD, Principal Investigator

Tampa Bay Urology, Tampa, Florida 33607, United States; Recruiting
Linda Seibert, Phone: 813-872-7881, Email: LA@ISRnet.com
Mark Swierzewski, MD, Principal Investigator

Medsearch Professional Group, Miami, Florida 33145, United States; Recruiting
Francisco Diaz, Phone: 305-443-2308, Email: FDiazMedSearch@aol.com
Eduardo Viera, MD, Principal Investigator

Women's Medical Research Group, LLC, Clearwater, Florida 33759, United States; Recruiting
Gayle Cameron, Phone: 727-724-9730, Email: gaylec@xxresearch.com
Edward Zbella, MD, Principal Investigator

Southeastern Medical Research Institute, Columbus, Georgia 31904, United States; Recruiting
Stephanie Thomas, Phone: 706-324-7080, Email: thomass@harperurology.com
William Harper, MD, Principal Investigator

Albert F. Johary,MD, PC, Dunwoody, Georgia 30338, United States; Recruiting
Leslie Shier, Phone: 770-730-8908, Email: leslie@albertjoharymd.com
Albert Johary, MD, Principal Investigator

Accelovance, Peoria, Illinois 61602, United States; Recruiting
Sara Riggenbach, Phone: 309-672-1910, Ext: 116, Email: sriggenback@accelovance.com
Daniel Brune, MD, Principal Investigator

Radiant Research, Kansas City, Overland park, Kansas 66202, United States; Recruiting
Jean Davidson, Phone: 913-599-3333
Monica Pierson, MD, Principal Investigator

Regional Urology, LLC, Shreveport, Louisiana 71106, United States; Recruiting
Tracey Robinson, Phone: 318-683-0411, Email: trobinson@regionalurology.com
Kevin Cline, MD, Principal Investigator

Benchmark Research, Metairie, Louisiana 70006, United States; Recruiting
Cori Favalora, Phone: 504-888-9493
Robert Jeanfreau, Principal Investigator

Pierremont Women's Clinic, Shreveport, Louisiana 71111, United States; Recruiting
Paula Johnson, Phone: 318-308-2909, Email: pjohnson@researchsolutionscorp.com
Claude Lockhart, MD, Principal Investigator

FutureCare Studies, Inc., Springfield, Massachusetts 01103, United States; Recruiting
Annette Scarnici, Phone: 413-788-1400, Email: Annette.white@futurecarestudies.com
Adnan Dahdul, Principal Investigator

Radiant Research Inc., St. Louis, Missouri 63141, United States; Recruiting
Matthew Price, Phone: 314-692-2100, Email: matthewprice@radiantresearch.com
Bruce Berwald, MD, Principal Investigator

Women's Clinic of Lincoln, P.C, Lincoln, Nebraska 68510, United States; Recruiting
Hannah Brown, Phone: 402-441-0025, Email: hbrownnc@neb.rr.com
Stephen Swanson, MD, Principal Investigator

Sheldon J. Freedman, MD.,Ltd, Las Vegas, Nevada 89109, United States; Recruiting
Fiona Pougher, Phone: 702-732-0282, Ext: 235, Email: cwfreedman@aol.com
Sheldon Freedman, MD, Principal Investigator

Allan patrick, MD Professional Corporation, Fredericton, New Brunswick E3B 5B8, Canada; Recruiting
Kathryn McHatten, Phone: 506-444-9020, Email: clrpwork@nbnet.nb.ca
Allan Patrick, Principal Investigator

AdvanceMed Research (Melissa Ciatteo, Director - Main Study Coordinator), Lawrenceville, New Jersey 08648, United States; Recruiting
Melissa Ciatteo, Phone: 609-895-0735, Ext: 135, Email: miciatteo@advancemed.info

Morristown Urology, Morristown, New Jersey 07960, United States; Recruiting
Rosemary Stefiniw, Phone: 973-971-5990, Email: Rosemary.stefiniw@ahsys.org
David Chaiken, Principal Investigator

Lawrenceville Urology, Lawrenceville, New Jersey 08648, United States; Recruiting
Rosa Miceli, Phone: 609-895-1991, Email: rmiceli@lawrencevilleurology.com
Gary Karlin, MD, Principal Investigator

Urology Group of New Mexico, PC, Albuquerque, New Mexico 87109, United States; Recruiting
MaryLou Jones, Phone: 505-872-4090, Ext: 117, Email: studies@ugnm.com
Frederick Snoy, MD, Principal Investigator

Ferring Pharmaceutical Inc, Suffern, New York 10901, United States; Recruiting

Upstate Urology, Albany, New York 12206, United States; Recruiting
Linda Abriel, Phone: 518-446-9838, Email: labriel@upstateurology.com
James Barada, MD, Principal Investigator

AccuMed Research Associates, Garden City, New York 11530, United States; Recruiting
Kerri Weingard, Phone: 516-746-2190, Email: accumed@aol.com
Mitchell Efros, MD, Principal Investigator

University Urology Associates, New York, New York 10016, United States; Recruiting
Besty Ortiz, Phone: 212-686-9015, Ext: 9, Email: bmoclair@universityurology.com
Jed Kaminetsky, MD, Principal Investigator

Jay Motola,MD, Adult & Pediatric Urology, Carmel, New York 10512, United States; Recruiting
Donna Faiella, Phone: 845-279-1100, Email: dfaiella@motolaurology.com
Jay Motola, MD, Principal Investigator

Piedmont Medical Research Associates, Winston-Salem, North Carolina 27103, United States; Recruiting
Elizabeth Martin, Phone: 336-768-8062
David Cook, MD, Principal Investigator

New Hanover Medical Research, Wilmington, North Carolina 28401, United States; Recruiting
Marjorie Hall, Phone: 910-799-5500, Email: mhall@piedmontmedical.com
Robert Hutchins, MD, Principal Investigator

Northeast Urology Research, Concord, North Carolina 28025, United States; Recruiting
Page Lev, Phone: 704-786-2931, Email: crc@neurr.com
David Lipsitz, Principal Investigator

PharmQuest, Greensboro, North Carolina 27401, United States; Recruiting
Michele Foster, Phone: 336-574-8020, Ext: 303, Email: mfoster@pharmquest.biz
Alexander Murray, MD, Principal Investigator

Radiant Research - Akron, Mogadore, Ohio 44260, United States; Recruiting
Teri Cottrill, Phone: 330-628-6001
Dennis McCluskey, MD, Principal Investigator

Radiant Research, Cincinnati, Ohio 45249, United States; Recruiting
Jeanne Blevins, Phone: 513-247-5577, Email: jeanneblevins@radiantresearch.com
Michael Noss, Principal Investigator

The Fe/Male Health Centres, Oakville, Ontario L6H 3P1, Canada; Recruiting
Ammar Mahmood, Phone: 905-338-3130, Email: ammar_mahmood@hotmail.com
Richard Casey, MD, Principal Investigator

Dr. Goldfarb's Office, North Bay, Ontario P1B 4Z2, Canada; Recruiting
Terri Moreau, Phone: 705-474-1148, Email: drgoldfarb@bellnet.ca
Bernard Goldfarb, Principal Investigator

Sunnybrook Health Sciences Centre, Toronto, Ontario M4N 3M5, Canada; Recruiting
Divina Buencamino, Phone: 416-480-6100, Ext: 2309, Email: divina.buencamino@sunnybrook.ca
Sender Herschorn, MD, Principal Investigator

Guelph Urology Associates, Guelph, Ontario N1H 5J1, Canada; Recruiting
Catherine Manicom, Phone: 519-824-7272
Eric Hirshberg, Principal Investigator

Brantford Urology Research, Brantford, Ontario N3R 4N3, Canada; Recruiting
Nora Leung, Phone: 519-753-9221, Email: noraleung@rogers.com
Wilson Leung, Principal Investigator

The Male/Female Health and Reserach, Barrie, Ontario L4M 7G1, Canada; Recruiting
Judy Cannon, Phone: 705-727-0551, Email: judymhc@bmts.com
Joseph Zadra, MD, Principal Investigator

Urologic Consultants of SE PA, Bala Cynwyd, Pennsylvania 19004, United States; Recruiting
Karen Hulick, Phone: 610-667-3020, Email: urologicresearch@attglobal.net
Lawrence Belkoff, MD, Principal Investigator

Advanced Clinical Concepts, Reading, Pennsylvania 19611, United States; Recruiting
Jan Petrie, Phone: 610-374-2214, Ext: 3076, Email: janp@advancedclinicalconcepts.com
Stephen Fehnel, Principal Investigator

Radiant Research, Philadelphia, Pennsylvania 19115, United States; Recruiting
Dana O'Neill, Phone: 215-671-1717
Barry Packman, MD, Principal Investigator

Philadelphia Clinical Research, LLC, Philadelphia, Pennsylvania 19114, United States; Recruiting
Caryn Linsky, Phone: 215-676-6696
Larry Seidman, MD, Principal Investigator

Radiant Research, Greer, Greer, South Carolina 29651, United States; Recruiting
Denise Rishel, Phone: 864-877-9239
William Ellison, MD, Principal Investigator

University Medical Group, Greenville, South Carolina 29605, United States; Recruiting
Jeffrey Garris, Phone: 864-455-5566
Jeffrey Garris, Principal Investigator

Palmetto Medical Research, Mt. Pleasant, South Carolina 29464, United States; Recruiting
Holly Nelson, Phone: 843-849-1880, Email: hnelson@piedmontmedical.com
Richard Mills, MD, Principal Investigator

Carolina Urologic Research Center, Myrtle Beach, South Carolina 29572, United States; Recruiting
Wanda Dunn, Phone: 843-839-1679, Email: wdunn@grandstrandurology.com
Brian Roberts, MD, Principal Investigator

Vanderbilt University Medical Center, Nashville, Tennessee 37232, United States; Recruiting
Mary Huges, Phone: 615-343-5602, Email: brenda.Hughes@vanderbilt.edu
Roger Dmochowski, MD, Principal Investigator

Holston Mdeical Group, Kingsport, Tennessee 37660, United States; Recruiting
Joyce Caldwell, Phone: 423-578-1506, Email: jac@hmgkpt.com
Emily Morawski, MD, Principal Investigator

Regional Medical Center and Diagnostic, Humble, Texas 77338, United States; Recruiting
Asma Hashmi, Phone: 281-446-9676, Ext: 129, Email: emailasmahashmi@yahoo.com
George Brooks, MD, Principal Investigator

Advanced Research Associates, Corpus Christi, Texas 78414, United States; Recruiting
Bonne Gutierrez, Phone: 361-906-1277, Email: bonnie@araresearch.com
Charles Eubank, Jr., MD, Principal Investigator

Radiant Research San Antonio, San Antonio, Texas 78228, United States; Recruiting
Martha Ricketson, Phone: 210-614-7483
William Jennings, MD, Principal Investigator

Accelovance, Houston, Texas 77024, United States; Recruiting
Byron Bookter, Phone: 713-932-1234, Email: bbookter@accelovance.com
David Mobley, MD, Principal Investigator

Urology San Antonio Research, PA, San Antonio, Texas 78229, United States; Recruiting
Beatrice Escamilla, Phone: 210-617-4116, Email: Beatrice.escamilla@urologysaresearch.com
Daniel Saltzstein, MD, Principal Investigator

Health Central Women's Care, Dallas, Texas 75231, United States; Recruiting
Lynette Karasz, Phone: 214-365-1150, Ext: 1046, Email: lkarasz@researchsolutionscorp.com
Jay Staub, MD, Principal Investigator

Urologyof Virginia PC, Virginia Beach, Virginia 23454, United States; Recruiting
Suzzane Smith, Phone: 757-457-5462
Gregg Eure, Principal Investigator

Virginia Urology Center, Richmond, Virginia 23235, United States; Recruiting
Janeet Sorah, Phone: 804-288-2785, Ext: 801
Anthony Sliwinski, MD, Principal Investigator

Stanley Flax medical Professional, Seattle, Washington 98166, United States; Recruiting
Tracy Hobbins, Phone: 905-791-4529, Email: tracyhobbins@hotmail.com
Stanley Flax, MD, Principal Investigator

Seattle Urology Research Center, Seattle, Washington 98166, United States; Recruiting
Angel Felipa, Phone: 206-243-3701, Email: surc@comcast.net
Jeffrey Frankel, MD, Principal Investigator

Women's Clinical Research Center, Seattle, Washington 98105, United States; Recruiting
Pavlina Barcal, Phone: 206-522-3330
Robin Kroll, MD, Principal Investigator

Starting date: May 2007
Ending date: March 2008
Last updated: July 10, 2008