NCT01848730

Efficacy and Safety of CNV2197944 Versus Placebo in Patients With Post-herpetic Neuralgia

A Randomised Double-blind Crossover Study to Compare the Efficacy and Safety of CNV2197944 75 mg Tid Versus Placebo in Patients With Post-herpetic Neuralgia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Convergence Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

To investigate the effect of repeat oral dosing of CNV2197944 75 mg tid on the pain experienced in post-herpetic neuralgia (PHN) as measured by changes in PI-NRS after three weeks of treatment compared to the baseline period.

Detailed description

A 3 week randomised crossover study to investigate the effect of repeat oral dosing of CNV2197944 75 mg tid versus placebo for on the pain experienced in post-herpetic neuralgia (PHN. Each 3 week treatment period is seperated by a 2 week washout period. The primary outcome measure is the change from baseline in the PI-NRS after three weeks of treatment. Secondary outcome measures include pain responder rates, clinical and patient global impressions of pain, and the Neuropathic Pain Symptom Inventory.

Conditions

• Post-herpetic Neuralgia

Interventions

Type	Name	Description
DRUG	CNV2197944
DRUG	Placebo

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-02-01
• Completion: 2014-05-01
• First posted: 2013-05-07
• Last updated: 2014-10-30

Locations

1 site across 1 country: South Africa