Status:
COMPLETED
A Multi-Centre, Randomized, Double-Blind, Placebo Controlled Pilot Trial to Assess the Efficacy, Safety, and Tolerability of SPM 927 in Subjects With Postherpetic Neuralgia (PHN).
Lead Sponsor:
UCB Pharma
Conditions:
Postherpetic Neuralgia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The objective of the trial is to investigate the analgesic efficacy of SPM 927 in subjects with moderate to severe neuropathic pain due to Postherpetic Neuralgia (PHN)
Eligibility Criteria
Inclusion
- Subject has clinically diagnosed painful postherpetic neuralgia present at least six months after healing of a herpes zoster skin rash and has at least one form of allodynia
- Subject must have at least moderate pain (mean pain intensity ≥ 4 out of 10 during the baseline week on Likert scale).
Exclusion
- Subject has other conditions that cause pain at least as severe as the postherpetic neuralgia.
- Subject has had any surgical treatment or any neurolytic injections for PHN
- Subject has clinically significant ECG and laboratory abnormalities.
- Subject is receiving treatment with anti-epileptic drugs (AEDs), muscle relaxants, mexiletine, topical analgesics, antidepressants, opioids, non-steroidal anti-inflammatory drugs (NSAIDs), paracetamol, benzodiazepines, and antiviral agents.
- Subject has liver function tests (AST, ALT, alkaline phosphatase, total bilirubin and GGT out of the reference range) \> 1,5 x ULN (upper limit of normal) at visit 1
- Subject has serum creatinine ≥ 2 times the upper limit of reference range at Visit 1.
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2003
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00861068
Start Date
February 1 2002
End Date
January 1 2003
Last Update
April 19 2024
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