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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00455520
• Date of registration: 01/04/2007
• Primary sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Public title: A Safety and Efficacy Study for Tapentadol (CG5503) Extended Release for Patients With Painful Diabetic Peripheral Neuropathy
• Scientific title: A Randomized-Withdrawal Phase 3 Study Evaluating the Safety and Efficacy of CG5503 Extended Release (ER) in Subjects With Painful Diabetic Peripheral Neuropathy
• Date of first enrolment: March 2007
• Target sample size: 395
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00455520
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

Canada, United States

Contacts

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

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetic Neuropathy

Intervention(s)

Drug: CG5503

Drug: placebo

Primary Outcome(s)

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 [Time Frame: Baseline and 12 weeks]

Secondary Outcome(s)

Change From Baseline in Brief Pain Inventory (BPI) Total Pain Score Over the Last Week of the Maintenance Period at Week 12. [Time Frame: Baseline and12 week endpoint]

Change From Baseline in EuroQol-5 (EQ-5D) Health Status Index to Week 12 [Time Frame: 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. [Time Frame: Baseline and 12 week endpoint]

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 [Time Frame: 12 week endpoint]

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. [Time Frame: Start of Open Label and at 12 weeks of Double Blind]

Secondary ID(s)

CR012466

R33133PAI3015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Grünenthal GmbH