[S,S]-Reboxetine Add-On Trial

Phase 2

Terminated

• Conditions: Pain
• Interventions: Drug: [S,S]-Reboxetine + Pregabalin; Drug: Pregabalin

• Registration Number: NCT00334685
• Lead Sponsor: Pfizer

Brief Summary

The purpose of this study is to determine the effectiveness of adjunctive treatment of pregabalin with \[S,S\]-Reboxetine against pregabalin monotherapy in patients with PHN

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-06-07
• Study First Submitted QC: 2006-06-07
• Study First Posted: 2006-06-08
• Study Start: 2006-08-22
• Primary Completion: 2007-10-04
• Study Completion: 2007-10-11
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-12
• Last Update Posted: 2019-12-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

• Patients must have pain present for more than 3 months after the healing of shingles skin rash
• Patients at screening must have a score >/=40 mm on the pain visual analogue scale

Exclusion Criteria

• Patients with significant renal and hepatic impairment
• Patients with other severe pain, that may impair the self-assessment of the pain due to shingles
• Patients with clinically abnormal electrocardiogram

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
[S,S]-Reboxetine + Pregabalin	[S,S]-Reboxetine + Pregabalin	-
Pregabalin	Pregabalin	-

Primary Outcome Measures

Name	Time	Method
The numerical pain intensity rating scale is used to assess pain and a change from baseline in pain score for week 10 will be calculated	Week 10

Secondary Outcome Measures

Name	Time	Method
The mean endpoint (week 10) sleep interference score change from baseline	Week 10
Analysis of the Medical Outcomes Study Sleep Scale	Week 10
Analysis of the Patient Global Impression of Change	Week 10
Analysis of the Neuropathic Pain Symptom Inventory	Week 10

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 York, United Kingdom