A Study to Compare the Frequency of Constipation Symptoms With Tapentadol Immediate Release (IR) Treatment Versus Oxycodone IR Treatment in Patients With End-Stage Joint Disease

Condition(s) targeted: Joint Disease; Arthritis; Analgesics; Analgesia; Osteoarthritis

Intervention: oxycodone IR (Drug); Tapentadol IR (CG5503) (Drug); Tapentadol IR (CG5503) (Drug); Placebo (Drug); Tapentadol ER(CG5503) (Drug); oxycodone CR (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Official(s) and/or principal investigator(s):
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Overall contact:
Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: info1@veritasmedicine.com

The purpose of this study is to compare bowel function/constipation that occurs during tapentadol treatment with that occuring during oxycodone treatment, as measured by the frequency of spontaneous bowel movements per week. The frequency of spontaneous bowel movements will be determined from a Bowel Function Patient Diary completed by the enrolled patients.

Official title: A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Arm, Multicenter Study in Subjects With End-Stage Joint Disease to Compare the Frequency of Constipation Symptoms in Subjects Treated With Tapentadol IR and Oxycodone IR Using a Bowel Function Patient Diary

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

Primary outcome: The primary endpoints are the 5-day Sum of Pain Intensity Difference (SPID) and the Number of Spontaneous Bowel Movements per Week.

Secondary outcome: The secondary endpoints are derived pain severity and relief measures and the severity of constipation associated bowel symptoms.

Detailed description: Chronic pain from end-stage degenerative joint disease is often moderate to severe in intensity and results in a relatively constant level of pain requiring continuous pain relief medication. Despite available pain relief medications, 60% to 80% of patients suffering from chronic pain are currently inadequately treated. Opioid pain medications are central to the effective treatment of moderate to severe pain. However, opioid therapy is frequently complicated by side effects. Constipation is one of the most commonly reported side effects and most debilitating. An opioid medication that provides pain relief with a reduced incidence of constipation symptoms would improve the capability of patients to stay on medication to achieve the long-term relief they need. This is a randomized, double-blind, placebo- and active-controlled, parallel-arm, multicenter study with 4 treatment groups of patients who have moderate to severe chronic pain from end-stage degenerative joint disease of the hip or knee and who are candidates for primary total or partial joint replacement. The study consists of 3 periods: a pretreatment period (a 14-day screening for study eligibility and a 7-day washout of any previously taken opioid medication), a double-blind treatment period (a 14-day IR treatment phase followed by a 28-day extended-release [ER] treatment phase), and a follow-up period (1 study-site visit within 4 days after the last dose of study drug is taken and 1 telephone contact within 10 to 14 days after the last dose of study drug is taken). On Day 1 of the IR treatment phase, patients will be randomly assigned to 1 of 4 possible treatment groups to receive 50 mg tapentadol IR, 75 mg tapentadol IR, 10 mg oxycodone IR, or placebo daily every 4 to 6 hours. At the beginning of the ER treatment phase, patients' study drugs will be transitioned to the ER form (by conversion from the IR to approximate equivalent total daily doses of the ER form) of their randomly assigned study drug of tapentadol ER, oxycodone controlled release (CR), or placebo. The ER study drugs will be taken every 12 hours b. i.d. Dosages will be adjustable, with the study site personnel oversight, to ensure adequate pain relief is provided. Beginning with the washout period, patients will be given hand-held computer diaries in which to record their pain intensity, pain relief, bowel movement information, and answer questions on any nausea or vomiting that may occur. In addition, patients will write down the times and dosages of all medications they take during the study in a medication diary. Safety and tolerability will be assessed using physical examination, monitoring of adverse events, clinical and laboratory measures, and 12 lead ECG results. The first study hypothesis is that both tapentadol IR dosages are more effective than placebo in relieving pain based on the Sum of Pain Intensity Difference (SPID) score recorded by the patients over the first 5 days of the study. The second study hypothesis is that the Bowel Function Patient Diary results for both tapentadol IR dosages demonstrate improved tolerability compared to oxycodone IR 10 mg, based on the number of spontaneous bowel movements per week over the first 2 weeks of the study.

In the IR treatment phase, each patient will take tapentadol IR 50 mg, tapentadol IR 75 mg, oxycodone IR 10 mg, or placebo orally every 4 to 6 hours for 14 days. In the ER treatment phase, dosages of the IR treatment groups will be converted to approximately equivalent dosages of the ER form of the assigned study drug: tapentadol ER, oxycodone CR, or placebo. Dosages may range from 100 to 500 mg/day of tapentadol ER and 20 to 60 mg/day of oxycodone CR taken orally every 12 hours for 28 days.

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- A clinical diagnosis of osteoarthritis of the hip or knee

- End-stage degenerative joint disease

- Eligibility for primary unilateral total or partial joint replacement surgery

- Pain level moderate to severe and at such a level as to require daily doses of an

opioid analgesic medication

Exclusion Criteria:

- Has a life-long history of seizure disorder or epilepsy

- Had any of the following within the preceding 1 year: mild or moderate traumatic brain

injury, stroke, transient ischemic attack, or brain neoplasm

- Had a severe traumatic brain injury within 15 years of screening (consisting of one or

more of the following: brain contusion, intracranial hematoma, either unconsciousness or post traumatic amnesia lasting for more than 24 hours)

- Joint pain not associated with gout, fibromyalgia, rheumatoid arthritis, other

autoimmune disease

- History of alcohol or drug abuse

- Chronic hepatitis B and C or HIV, active hepatitis B and C within 3 months

- Severely impaired renal function or moderately to severely impaired hepatic function

- History of cancer within past 2 years

Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: info1@veritasmedicine.com

Mobile, Alabama 36608, United States; Recruiting

Mesa, Arizona 85206, United States; Recruiting

Phoenix, Arizona 85023, United States; Recruiting

Tucson, Arizona 85741, United States; Recruiting

Coquitlam, British Columbia V3K 3P4, Canada; Recruiting

Chilliwack, British Columbia V2P 4M9, Canada; Recruiting

Burnaby, British Columbia V5G 1T4, Canada; Recruiting

Huntington Park, California 90255, United States; Recruiting

Foothill Ranch, California 92610, United States; Recruiting

Westlake Village, California 91361, United States; Recruiting

Trumbull, Connecticut 06611, United States; Recruiting

Jacksonville, Florida 32216, United States; Recruiting

Deland, Florida 32720, United States; Recruiting

Tampa, Florida 33603, United States; Recruiting

Oldsmar, Florida 34677, United States; Recruiting

Port Orange, Florida 32127, United States; Recruiting

Ormond Beach, Florida 32174, United States; Recruiting

Tamarac, Florida 33321, United States; Not yet recruiting

Miami, Florida 33186, United States; Recruiting

Woodstock, Georgia 30189, United States; Recruiting

Marietta, Georgia 30060, United States; Recruiting

Perry, Georgia 31069, United States; Recruiting

Honolulu, Hawaii 96814, United States; Recruiting

Boise, Idaho 83702, United States; Recruiting

Bloomington, Illinois 61701, United States; Not yet recruiting

Evansville, Indiana 47714, United States; Recruiting

West Des Moines, Iowa 50265, United States; Recruiting

Lake Charles, Louisiana 70601, United States; Recruiting

New Orleans, Louisiana 70114, United States; Recruiting

Covington, Louisiana 70433, United States; Recruiting

Mandeville, Louisiana 70471, United States; Not yet recruiting

Metairie, Louisiana 70006, United States; Recruiting

New Orleans, Louisiana 70115, United States; Recruiting

Baton Rouge, Louisiana 70809, United States; Recruiting

Fall River, Massachusetts 02720, United States; Not yet recruiting

Wellesley Hills, Massachusetts 02481, United States; Recruiting

W Yarmouth, Massachusetts 02673, United States; Recruiting

N Dartmouth, Massachusetts 02747, United States; Recruiting

Traverse City, Michigan 49684, United States; Recruiting

Troy, Michigan 48098, United States; Recruiting

St. Louis, Missouri 63141, United States; Not yet recruiting

Saint Louis, Missouri 63141, United States; Recruiting

Omaha, Nebraska 68134, United States; Recruiting

Cherry Hill, New Jersey 08002, United States; Recruiting

Morristown, New Jersey 07960, United States; Not yet recruiting

New York, New York 10022, United States; Not yet recruiting

Greenville, North Carolina 29615, United States; Recruiting

Hickory, North Carolina 28601, United States; Recruiting

Cincinnati, Ohio 45242, United States; Recruiting

Kettering, Ohio 45429, United States; Recruiting

Oklahoma City, Oklahoma 73139, United States; Recruiting

Oklahoma City, Oklahoma 73116, United States; Recruiting

Oklahoma City, Oklahoma 73109, United States; Recruiting

Oklahoma City, Oklahoma 73119, United States; Recruiting

Toronto, Ontario M4S 1Y2, Canada; Recruiting

Brampton, Ontario L6W 3E1, Canada; Recruiting

London, Ontario N5X 4E7, Canada; Recruiting

Oshawa, Ontario L1J 2J2, Canada; Recruiting

Scarborough, Ontario M1E 5E9, Canada; Recruiting

Corunna, Ontario N0N 1G0, Canada; Recruiting

Vancouver, Ontario V6Z 2E8, Canada; Recruiting

Sudbury, Ontario P3E 1H5, Canada; Recruiting

Toronto, Ontario M4P 1E8, Canada; Recruiting

Listowel, Ontario N4W 2P4, Canada; Recruiting

Sarnia, Ontario N7T 4X3, Canada; Recruiting

Waterloo, Ontario N2T 2Z6, Canada; Recruiting

Mississauga, Ontario L5N 6S5, Canada; Recruiting

Newmarket, Ontario L3Y 5G8, Canada; Recruiting

London, Ontario N5W 3C6, Canada; Recruiting

Duncansville, Pennsylvania 16635, United States; Recruiting

Montreal, Quebec H3T 1E2, Canada; Recruiting

Pointe-Claire, Quebec H9R 3J1, Canada; Recruiting

Regina, Saskatchewan S4P 3X1, Canada; Recruiting

Spartanburg, South Carolina 29302, United States; Recruiting

Sioux Falls, South Dakota 57104, United States; Not yet recruiting

Rapid City, South Dakota 57702, United States; Recruiting

Clarksville, Tennessee 37043, United States; Not yet recruiting

San Antonio, Texas 78229, United States; Recruiting

San Antonio, Texas 78238, United States; Recruiting

Odessa, Texas 79761, United States; Recruiting

Amarillo, Texas 79106, United States; Recruiting

Austin, Texas 78757, United States; Recruiting

Hurst, Texas 76054, United States; Recruiting

Dallas, Texas 75243, United States; Recruiting

Grapevine, Texas 76051, United States; Recruiting

Dallas, Texas 75246, United States; Recruiting

Draper, Utah 84020, United States; Recruiting

Virginia Beach, Virginia 23454, United States; Recruiting

To learn how to participate in this trial please click here.

Starting date: October 2008
Ending date: September 2009
Last updated: January 29, 2009