Status:
COMPLETED
A Trial to Investigate Safety and Efficacy of SPM927 in Painful Diabetic Neuropathy
Lead Sponsor:
UCB Pharma
Conditions:
Painful Diabetic Neuropathy
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The primary purpose is to investigate the safety and efficacy of SPM927 in patients with Painful Diabetic Neuropathy
Eligibility Criteria
Inclusion
- Subject has clinically diagnosed pain attributed to diabetic distal sensory motor polyneuropathy for 1-5 years and a diagnosis of diabetes mellitus (Type I or Type II).
- Subjects must have at least moderate pain (mean pain intensity ≥ 4 out of 10 during the baseline week on Likert scale).
- subjects must have good or fair diabetic control (Hgb A1c \< 10%)
Exclusion
- Subject has other conditions that cause neuropathic pain at least as severe as the diabetic pain i.e. peripheral arterio-vascular disease.
- Subject receives treatment for seizures.
- Subject has had any amputations other than diabetically-related toe amputations.
- Subject has major skin ulcers.
- Subject has clinically significant ECG abnormalities.
- Subject is expected to take within 7 days prior to randomization and during the study: TCAs, mexiletine hydrochloride, lidoderm patch, tramadol, AEDs, dextromethorphan, opioids, capsaicin, nonsteroidal anti-inflammatory drugs, acetaminophen / paracetamol, skeletal muscle relaxants, benzodiazepines, alpha-2-agonists (e.g. clonidine), drugs indicated for sleep disturbance (e. g. zolpidem tartrate, zaleplon) and over-the-counter medications with centrally acting properties.
- Subject has laboratory values which are outside the normal range and judged by the investigator to be clinically significant.
- At study entry, subject has liver function tests values (AST, ALT,alkaline phosphatase, total bilirubin and GGT) 2 times upper limit of normal.
- subject has impaired renal function, i.e., creatinine clearance is lower than 60 mL/min.
Key Trial Info
Start Date :
June 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2003
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT00861445
Start Date
June 1 2001
End Date
February 1 2003
Last Update
October 20 2014
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.