A Study is to Evaluate the Efficacy, Safety, and Tolerability of Orally Administered Tapentadol ER at Dosages of 100 to 250 mg Twice Daily Compared With Placebo in Patients With Moderate to Severe Pain Due to Chronic, Painful Diabetic Peripheral Neuropathy (DPN)

Condition(s) targeted: Diabetic Neuropathy, Painful; Diabetic Polyneuropathy

Intervention: placebo (Drug); tapentadol extended release (ER) (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 & 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 evaluate the efficacy, safety, and tolerability of orally administered tapentadol ER at dosages of 100 to 250 mg twice daily compared with placebo in patients with moderate to severe pain due to chronic, painful diabetic peripheral neuropathy (DPN) who have an initial treatment effect (pain improvement) after a 3-week, open-label titration period.

Official title: A Randomized-Withdrawal, Placebo-Controlled, Study Evaluating the Efficacy, Safety, and Tolerability of Tapentadol Extended-Release (ER) in Subjects With Chronic, Painful Diabetic Peripheral Neuropathy (DPN)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: The mean change from baseline to the end of the 12-week double-blind maintenance phase in the score for average pain intensity on an 11 point Numerical Rating Scale (NRS).

Secondary outcome:

Change from baseline in the Patient Global Impression of Change (PGIC)

Change from baseline in the Brief Pain Inventory (BPI),

Change from baseline in pain intensity score using the 11 point Numerical Rating Scale (NRS)

Change from baseline in the EuroQoL-5 Dimension (EQ-5D) health related functional status

Detailed description: This is a randomized-withdrawal (only patients that have an initial response to tapentadol are assigned to either tapentadol or placebo), placebo-controlled, multicenter study evaluating the efficacy, safety, and tolerability of orally administered tapentadol, using the extended release tamper-resistant formulation (TRF), at dosages of 100 to 250 mg twice daily in patients with moderate to severe pain due to chronic, painful DPN. The study consists of 1) an open-label (all people involved know the identity of the intervention) phase, including a 13-day screening period, a 5-day washout period (where patients are to stop taking their pain medication), a 3-day pre-titration pain-intensity evaluation period (where patients will record their pain intensity twice daily in the morning and evening), and a 3-week, open-label titration period (all patients receive tapentadol study drug), 2) a 12-week, double-blind (neither physician nor patient knows the name of the assigned drug) maintenance phase, and 3) a posttreatment phase of approximately 10 to 14 days. The study will evaluate the effectiveness of orally administered tapentadol ER versus placebo in reducing patients' pain intensity. The pain intensity will be assessed by comparing the baseline pain level to the level at week 12 of the maintenance phase. The total duration of study drug treatment for each patient will be approximately 15 weeks. Safety and tolerability will be evaluated by vital signs, physical examinations, clinical laboratory tests, 12-lead electrocardiograms (ECGs), standardized neurologic examinations and monitoring of adverse events. Titrate tapentadol extended release (ER) 50mg twice daily to patient's optimal dose ranging between 100 mg ad 250 mg twice a day; placebo (no active ingredients). All doses of study medication will be taken orally with approximately 120mL of water with or without food for a maximum timeframe of 15 weeks.

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

Criteria:

Inclusion Criteria:

- Patients with Type 1 or 2 diabetes mellitus must have a documented clinical diagnosis

of painful diabetic peripheral neuropathy with symptoms and signs for at least 6 months, and pain present at the time of screening

- Diagnosis must include pain plus reduction or absence of pin sensibility and/or

vibration sensibility on Total Neuropathy Score - Nurse (TNSn) examination in lower

and/or upper extremities at screening

- The investigator considers the patient's blood glucose to be controlled by diet, or

hypoglycemics, or insulin for at least 3 months prior to enrolling in the study (this control should be documented by figures of glycated hemoglobin (HbA1c) no greater than 11% at screening)

- Patients have been taking analgesic medications for the condition for at least 3

months prior to screening (patients taking opioid analgesics must be dissatisfied with current treatment, and patients taking non-opioid analgesics must be dissatisfied with current analgesia)

- Patients currently requiring opioid treatment must be taking daily doses of an

opioid-based analgesic equivalent to <=160mg of oral morphine

Exclusion Criteria:

- Significant history of pulmonary, gastrointestinal, endocrine, metabolic (except

diabetes mellitus), neurological, psychiatric disorders (resulting in disorientation, memory impairment or inability to report accurately as in schizophrenia)

- History of moderate to severe hepatic impairment

- Severely impaired renal function

- Clinically significant laboratory abnormalities

- Clinically significant cardiac disease

- History of seizure disorder or epilepsy

- History of any other clinically significant disease that in the investigator's

opinion may affect efficacy or safety assessments or may compromise patient safety during study participation.

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

San Juan, Puerto Rico; Completed

Mobile, Alabama, United States; Recruiting

Calgary, Alberta, Canada; Recruiting

Chandler, Arizona, United States; Recruiting

Mesa, Arizona, United States; Recruiting

Phoenix, Arizona, United States; Recruiting

Kelowna, British Columbia, Canada; Recruiting

Burbank, California, United States; Completed

Fresno, California, United States; Suspended

Laguna Hills, California, United States; Completed

Lakewood, California, United States; Completed

Norco, California, United States; Completed

Orange, California, United States; Recruiting

Redding, California, United States; Recruiting

Roseville, California, United States; Not yet recruiting

Sacramento, California, United States; Active, not recruiting

San Francisco, California, United States; Recruiting

Spring Valley, California, United States; Recruiting

Walnut Creek, California, United States; Recruiting

West Covina, California, United States; Completed

Denver, Colorado, United States; Recruiting

Clearwater, Florida, United States; Recruiting

Hallandale Beach, Florida, United States; Recruiting

Miami, Florida, United States; Recruiting

Ormond Beach, Florida, United States; Recruiting

St Petersburg, Florida, United States; Recruiting

Tampa, Florida, United States; Recruiting

West Palm Beach, Florida, United States; Recruiting

Atlanta, Georgia, United States; Recruiting

Marietta, Georgia, United States; Recruiting

Boise, Idaho, United States; Recruiting

Eagle, Idaho, United States; Recruiting

Meridian, Idaho, United States; Completed

Avon, Indiana, United States; Recruiting

Evansville, Indiana, United States; Recruiting

Fishers, Indiana, United States; Not yet recruiting

Prairie Village, Kansas, United States; Recruiting

Shreveport, Louisiana, United States; Recruiting

Owings Mills, Maryland, United States; Recruiting

Pasadena, Maryland, United States; Recruiting

Rockville, Maryland, United States; Recruiting

Brockton, Massachusetts, United States; Recruiting

Edina, Minnesota, United States; Recruiting

Saint Louis, Missouri, United States; Recruiting

Cedarhurst, New York, United States; Recruiting

Flushing, New York, United States; Recruiting

New York, New York, United States; Recruiting

Rochester, New York, United States; Recruiting

Valley Stream, New York, United States; Not yet recruiting

Williamsville, New York, United States; Recruiting

Flat Rock, North Carolina, United States; Suspended

Hickory, North Carolina, United States; Recruiting

Akron, Ohio, United States; Recruiting

Cincinnati, Ohio, United States; Recruiting

Barrie, Ontario, Canada; Recruiting

Hamilton, Ontario, Canada; Terminated

Hamilton, Ontario, Canada; Recruiting

Hawkesbury, Ontario, Canada; Recruiting

Sarnia, Ontario, Canada; Recruiting

Sudbury, Ontario, Canada; Recruiting

Toronto, Ontario, Canada; Recruiting

Medford, Oregon, United States; Recruiting

Allentown, Pennsylvania, United States; Recruiting

Altoona, Pennsylvania, United States; Recruiting

Duncansville, Pennsylvania, United States; Recruiting

Dollard-Des-Ormeaux, Quebec, Canada; Recruiting

Montreal, Quebec, Canada; Recruiting

Anderson, South Carolina, United States; Recruiting

Greer, South Carolina, United States; Recruiting

Bulverde, Texas, United States; Recruiting

Dallas, Texas, United States; Recruiting

Houston, Texas, United States; Recruiting

Odessa, Texas, United States; Recruiting

San Antonio, Texas, United States; Recruiting

Salt Lake City, Utah, United States; Recruiting

Alexandria, Virginia, United States; Recruiting

Norfolk, Virginia, United States; Recruiting

Virginia Beach, Virginia, United States; Recruiting

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

Starting date: December 2009
Last updated: September 16, 2010