A Study to Evaluate the Efficacy, Safety, and Tolerability of Tapentadol ER Compared With Placebo in Patients With Chronic, Painful Diabetic Peripheral Neuropathy

NCT ID: NCT01041859

Last Updated: 2013-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 460 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2011-03-31

Brief Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of orally administered tapentadol extended release (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 tolerated tapentadol (ER) and have an initial treatment effect (pain improvement) after a 3-week, open-label titration period.

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. Patients will be titrated on tapentadol ER from a starting dose of 50 mg twice daily to the patient's optimal dose ranging between 100 mg and 250 mg twice a day, or placebo. All doses of study medication will be taken orally with approximately 120 ml of water with or without food for a maximum timeframe of 15 weeks.

Conditions

Diabetic Peripheral Neuropathy

Keywords

Diabetic Peripheral Neuropathy; Painful; Polyneuropathy; Peripheral neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Tapentadol Extended Release (ER)

Group Type: EXPERIMENTAL

Tapentadol extended release (ER)

Intervention Type: DRUG

Type= range, unit= mg, number= 100 to 250, form= tablet, route= oral use. Tapentadol ER optimal dose ranging between 100 mg and 250 mg twice daily for 15 weeks.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Form= tablet, route= oral use. Matching placebo twice daily.

Interventions

Tapentadol extended release (ER)

Type= range, unit= mg, number= 100 to 250, form= tablet, route= oral use. Tapentadol ER optimal dose ranging between 100 mg and 250 mg twice daily for 15 weeks.

Intervention Type: DRUG

Placebo

Form= tablet, route= oral use. Matching placebo twice daily.

Intervention Type: DRUG

Eligibility 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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Grünenthal GmbH

INDUSTRY

Sponsor Role: collaborator

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Locations

Mobile, Alabama, United States

Chandler, Arizona, United States

Mesa, Arizona, United States

Phoenix, Arizona, United States

Fresno, California, United States

Orange, California, United States

Redding, California, United States

Sacramento, California, United States

San Francisco, California, United States

Spring Valley, California, United States

Walnut Creek, California, United States

Denver, Colorado, United States

Clearwater, Florida, United States

Hallandale, Florida, United States

Miami, Florida, United States

Ormond Beach, Florida, United States

St. Petersburg, Florida, United States

Tampa, Florida, United States

West Palm Beach, Florida, United States

Atlanta, Georgia, United States

Marietta, Georgia, United States

Boise, Idaho, United States

Eagle, Idaho, United States

Meridian, Idaho, United States

Avon, Indiana, United States

Evansville, Indiana, United States

Fishers, Indiana, United States

Prairie Village, Kansas, United States

Shreveport, Louisiana, United States

Owings Mills, Maryland, United States

Pasadena, Maryland, United States

Rockville, Maryland, United States

Brockton, Massachusetts, United States

Edina, Minnesota, United States

St Louis, Missouri, United States

Cedarhurst, New York, United States

Flushing, New York, United States

New York, New York, United States

Rochester, New York, United States

Valley Stream, New York, United States

Williamsville, New York, United States

Hickory, North Carolina, United States

Akron, Ohio, United States

Cincinnati, Ohio, United States

Medford, Oregon, United States

Allentown, Pennsylvania, United States

Altoona, Pennsylvania, United States

Duncansville, Pennsylvania, United States

Anderson, South Carolina, United States

Greer, South Carolina, United States

Bulverde, Texas, United States

Dallas, Texas, United States

Houston, Texas, United States

Odessa, Texas, United States

San Antonio, Texas, United States

Schertz, Texas, United States

Salt Lake City, Utah, United States

Alexandria, Virginia, United States

Norfolk, Virginia, United States

Virginia Beach, Virginia, United States

Calgary, Alberta, Canada

Kelowna, British Columbia, Canada

Barrie, Ontario, Canada

Greater Sudbury, Ontario, Canada

Hamilton, Ontario, Canada

Hawkesbury, Ontario, Canada

Sarnia, Ontario, Canada

Toronto, Ontario, Canada

Dollard-des-Ormeaux, Quebec, Canada

Laval, Quebec, Canada

Montreal, Quebec, Canada

San Juan, , Puerto Rico

Countries

United States; Canada; Puerto Rico

Other Identifiers

R331333PAI3027

Identifier Type: OTHER

Identifier Source: secondary_id

KF56

Identifier Type: OTHER

Identifier Source: secondary_id

CR016051

Identifier Type: -

Identifier Source: org_study_id