Status:
COMPLETED
An Open-label follow-on Trial to Assess the Long-term Safety and Efficacy of Oral SPM 927 in Subjects With Diabetic Neuropathy
Lead Sponsor:
UCB Pharma
Conditions:
Painful Diabetic Neuropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary objective of the trial is to assess the tolerability and safety of long-term SPM 927 administration in subjects with diabetic neuropathy.
Eligibility Criteria
Inclusion
- Subject has successfully completed a previous trial with SPM 927 in diabetic neuropathy and, in the investigator's opinion, would benefit from long-term administration of SPM 927.
- Subject has stable, good or fair diabetic control (HbA1c ≤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 an amputation related to diabetes, other than toe amputation.
- Subject has major skin ulcers.
- Subject has clinically significant ECG abnormalities.
- Subject expects to take during the study: TCAs, mexiletine hydrochloride, lidoderm patch, tramadol, AEDs, dextromethorphan, opioids, capsaicin, skeletal muscle relaxants, benzodiazepines or 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.
- Subject has liver function tests (AST, ALT, alkaline phosphatase, total bilirubin, or GGT) ≥ 2x ULN at Visit 1.
- At Visit 1, subject has impaired renal function, i.e., creatinine clearance (ClCr) is lower than 60 mL/min.
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2005
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT00861042
Start Date
April 1 2002
End Date
March 1 2005
Last Update
January 29 2024
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