A Safety and Efficacy Study for Tapentadol (CG5503) Extended Release for Patients With Painful Diabetic Peripheral Neuropathy

NCT00455520 | Completed Phase 3 Results

• 2 other identifiers: CR012466R33133PAI3015
• Study Type: interventional
• Target: 395
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of Tapentadol (CG5503) extended release (ER) (base) compared to placebo in patients with moderate to severe pain from diabetic peripheral neuropathy.

Conditions

Diabetic Neuropathy

Keywords

Diabetic neuropathy; Painful Diabetic Polyneuropathy; Polyneuropathy; Peripheral neuropathy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline (at Randomization) in Average Pain Intensity on an 11-point Numerical Rating Scale (NRS) Over the Last Week of the Double-blind Maintenance Period at Week 12

  For this twice daily pain assessment, the subjects were to indicate the level of pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".

  Baseline and 12 weeks

Secondary Outcomes (5)

• The Number of Patients Achieving at Least 30% Improvement in Pain Score at Week 12 of the Double-blind Maintenance Period From the Start of the Open Label Period.

  Start of Open Label and at 12 weeks of Double Blind

• Percentage of Patients Who Reported Very Much Improved or Much Improved From Baseline in Patient Global Impression of Change Over the Last Week of the Maintenance Period at Week 12

  12 week endpoint

• Change From Baseline in EuroQol-5 (EQ-5D) Health Status Index to Week 12

  12 week endpoint (change from baseline)

• Change From Baseline in Sleep Latency Time in Hours Over the Last Week of the Maintenance Period at Week 12.

  Baseline and 12 week endpoint

• Change From Baseline in Brief Pain Inventory (BPI) Total Pain Score Over the Last Week of the Maintenance Period at Week 12.

  Baseline and12 week endpoint

Study Arms (2)

Placebo

PLACEBO COMPARATOR

placebo matching placebo twice daily for 12 weeks

Drug: placebo

CG5503

EXPERIMENTAL

CG5503 100, 150, 200, 250mg twice daily given for up to 15 weeks

Drug: CG5503

Interventions

CG5503 DRUG

100, 150, 200, 250 mg twice daily given for up to 15 weeks

CG5503

placebo DRUG

matching placebo twice daily for 12 weeks

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with Type 1 or Type 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
• 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 \<=160 mg of oral morphine

You may not qualify if:

• No significant pulmonary, gastrointestinal, endocrine, metabolic (except diabetes mellitus), neurological, psychiatric disorders (resulting in disorientation, memory impairment or inability to report accurately as in schizophrenia, Alzheimer's disease), or any other clinically significant disease that in the Investigator's opinion may affect efficacy or safety assessments or may compromise patient's safety during trial participation
• no history of moderate to severe hepatic impairment such as chronic hepatitis B or C, presence of active hepatitis B or C within the last 3 months or impaired hepatic function with ALT or AST greater than 3-fold ULN
• No patients with severely impaired renal function
• No laboratory values above or below limits of normal unless considered not clinically relevant by the Investigator
• No significant cardiac disease (e.g., unstable angina pectoris, angina pectoris Canadian Cardiovascular Society (CCS) class III-IV, acute myocardial infarction within the last 3 months, cardiac insufficiency New York Heart Association (NYHA) class III-IV) or significant vascular disease (e.g., peripheral arterial occlusive disease (PAOD) Fontaine class IIb-IV)
• no life-long history of seizure disorders or epilepsy

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead
• Grünenthal GmbH: collaborator

Related Publications (2)

• Afilalo M, Morlion B. Efficacy of tapentadol ER for managing moderate to severe chronic pain. Pain Physician. 2013 Jan;16(1):27-40.

  PMID: 23340531 DERIVED

• Schwartz S, Etropolski M, Shapiro DY, Okamoto A, Lange R, Haeussler J, Rauschkolb C. Safety and efficacy of tapentadol ER in patients with painful diabetic peripheral neuropathy: results of a randomized-withdrawal, placebo-controlled trial. Curr Med Res Opin. 2011 Jan;27(1):151-62. doi: 10.1185/03007995.2010.537589.

  PMID: 21162697 DERIVED

MeSH Terms

Conditions

Diabetic Neuropathies; Polyneuropathies; Peripheral Nervous System Diseases

Interventions

Tapentadol

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Senior Director, Clinical Leader
• Organization: Johnson & Johnson Pharmaceutical Research & Development

609-730-4537

Study Officials

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

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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2007
• First Posted: April 3, 2007
• Study Start: April 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: July 19, 2013
• Results First Posted: January 13, 2010

Record last verified: 2013-07