A 13-Week, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Postherpetic Neuralgia - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

October 31, 2006

Last Updated Date

April 14, 2009

Start Date ^†

September 2006

Current Primary Outcome Measures ^†

Mean Pain Scores at Endpoint [ Time Frame: Week13/discontinuation ] [ Designated as safety issue: No ]
Mean Pain Score at Endpoint by Groups of Subjects With Expected Similar Plasma Concentrations [ Time Frame: Week13/discontinuation ] [ Designated as safety issue: No ]
Number of Responders [ Time Frame: Week13/discontinuation ] [ Designated as safety issue: No ]
Mean Pain Scores at Week 1 [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
Mean Pain Scores at Week 2 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
Mean Pain Scores at Week 3 [ Time Frame: Week 3 ] [ Designated as safety issue: No ]
Mean Pain Scores at Week 4 [ Time Frame: Week4 ] [ Designated as safety issue: No ]
Mean Pain Scores at Week 5 [ Time Frame: Week 5 ] [ Designated as safety issue: No ]
Mean Pain Scores at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
Mean Pain Scores at Week 7 [ Time Frame: Week 7 ] [ Designated as safety issue: No ]
Mean Pain Scores at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Mean Pain Scores at Week 9 [ Time Frame: Week 9 ] [ Designated as safety issue: No ]
Mean Pain Scores at Week 10 [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
Mean Pain Scores at Week 11 [ Time Frame: Week 11 ] [ Designated as safety issue: No ]
Mean Pain Scores at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Mean Pain Scores at Week 13 [ Time Frame: Week 13 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Numerical rating scale for pain caused by postherpetic neuralgia after 13-week treatment of pregabalin/placebo

Change History

Complete list of historical versions of study NCT00394901 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Endpoint Sensory Scores of the Short-Form McGill Pain Questionnaire [ Time Frame: Week13/discontinuation ] [ Designated as safety issue: No ]
Endpoint Affective Scores of the Short-Form McGill Pain Questionnaire [ Time Frame: Week13/discontinuation ] [ Designated as safety issue: No ]
Endpoint Total Scores of the Short-Form McGill Pain Questionnaire [ Time Frame: Week13/discontinuation ] [ Designated as safety issue: No ]
Endpoint Visual Analogue Scale Scores of the Short-Form McGill Pain Questionnaire [ Time Frame: Week13/discontinuation ] [ Designated as safety issue: No ]
Endpoint Present Pain Intensity Scores of the Short-Form McGill Pain Questionnaire [ Time Frame: Week13/discontinuation ] [ Designated as safety issue: No ]
Mean Sleep Interference Scores at Endpoint [ Time Frame: Week13/discontinuation ] [ Designated as safety issue: No ]
Endpoint Medical Outcomes Study Sleep Scale Scores:Sleep Disturbance [ Time Frame: Week13/discontinuation ] [ Designated as safety issue: No ]
Endpoint Medical Outcomes Study Sleep Scale Scores:Snoring [ Time Frame: Week13/discontinuation ] [ Designated as safety issue: No ]
Endpoint Medical Outcomes Study Sleep Scale Scores:Awaken Short of Breath or With Headache [ Time Frame: Week13/discontinuation ] [ Designated as safety issue: No ]
Endpoint Medical Outcomes Study Sleep Scale Scores:Quantity of Sleep [ Time Frame: Week13/discontinuation ] [ Designated as safety issue: No ]
Endpoint Medical Outcomes Study Sleep Scale Scores:Sleep Adequacy [ Time Frame: Week13/discontinuation ] [ Designated as safety issue: No ]
Endpoint Medical Outcomes Study Sleep Scale Scores:Somnolence [ Time Frame: Week13/discontinuation ] [ Designated as safety issue: No ]
Endpoint Medical Outcomes Study Sleep Scale Scores:Overall Sleep Problem Index [ Time Frame: Week13/discontinuation ] [ Designated as safety issue: No ]
Endpoint Medical Outcomes Study Sleep Scale: Number of Participants With Optimal Sleep [ Time Frame: Week13/discontinuation ] [ Designated as safety issue: No ]
Endpoint Patient Global Impression Change [ Time Frame: Week13/discontinuation ] [ Designated as safety issue: No ]
Endpoint Clinical Global Impression Change [ Time Frame: Week13/discontinuation ] [ Designated as safety issue: No ]
Endpoint Short-Form 36-Item Health Survey Scores: Physical Functioning [ Time Frame: Week13/discontinuation ] [ Designated as safety issue: No ]
Endpoint Short-Form 36-Item Health Survey Scores: Role Limitations-Physical [ Time Frame: Week13/discontinuation ] [ Designated as safety issue: No ]
Endpoint Short-Form 36-Item Health Survey Scores: Bodily Pain [ Time Frame: Week13/discontinuation ] [ Designated as safety issue: No ]
Endpoint Short-Form 36-Item Health Survey Scores: General Health Perception [ Time Frame: Week13/discontinuation ] [ Designated as safety issue: No ]
Endpoint Short-Form 36-Item Health Survey Scores: Social Functioning [ Time Frame: Week13/discontinuation ] [ Designated as safety issue: No ]
Endpoint Short-Form 36-Item Health Survey Scores: Role Limitations-Emotional [ Time Frame: Week13/discontinuation ] [ Designated as safety issue: No ]
Endpoint Short-Form 36-Item Health Survey Scores: Vitality [ Time Frame: Week13/discontinuation ] [ Designated as safety issue: No ]
Endpoint Short-Form 36-Item Health Survey Scores: Mental Health [ Time Frame: Week13/discontinuation ] [ Designated as safety issue: No ]
Number of Patients Not Reporting Allodynia [ Time Frame: Week13/discontinuation ] [ Designated as safety issue: No ]
Number of Patients Not Reporting Hyperalgesia [ Time Frame: Week13/discontinuation ] [ Designated as safety issue: No ]
Mean Sleep Interference Scores at Week 1 [ Time Frame: week 1 ] [ Designated as safety issue: No ]
Mean Sleep Interference Scores at Week 2 [ Time Frame: week 2 ] [ Designated as safety issue: No ]
Mean Sleep Interference Scores at Week 3 [ Time Frame: week 3 ] [ Designated as safety issue: No ]
Mean Sleep Interference Scores at Week 4 [ Time Frame: week 4 ] [ Designated as safety issue: No ]
Mean Sleep Interference Scores at Week 5 [ Time Frame: week 5 ] [ Designated as safety issue: No ]
Mean Sleep Interference Scores at Week 6 [ Time Frame: week 6 ] [ Designated as safety issue: No ]
Mean Sleep Interference Scores at Week 7 [ Time Frame: week 7 ] [ Designated as safety issue: No ]
Mean Sleep Interference Scores at Week 8 [ Time Frame: week 8 ] [ Designated as safety issue: No ]
Mean Sleep Interference Scores at Week 9 [ Time Frame: week 9 ] [ Designated as safety issue: No ]
Mean Sleep Interference Scores at Week 10 [ Time Frame: week 10 ] [ Designated as safety issue: No ]
Mean Sleep Interference Scores at Week 11 [ Time Frame: week 11 ] [ Designated as safety issue: No ]
Mean Sleep Interference Scores at Week 12 [ Time Frame: week 12 ] [ Designated as safety issue: No ]
Mean Sleep Interference Scores at Week 13 [ Time Frame: week 13 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Daily Sleep Interference Diary, Short-form McGill Pain Questionnaire, MOS-Sleep Scale for sleep, Patient Global Impression of Change, Clinical Global Impression of Change, SF-36 Health Survey

Descriptive Information

Brief Title ^†

A 13-Week, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Postherpetic Neuralgia

Official Title ^†

A 13-Week, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study To Evaluate Efficacy And Safety Of Pregabalin In The Treatment Of Postherpetic Neuralgia

Brief Summary

The purpose of this study is to evaluate efficacy and safety of pregabalin in the treatment of postherpetic neuralgia in a dose-ranging manner.

Detailed Description

Study Phase

Phase II, Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Caregiver), Parallel Assignment, Efficacy Study

Condition ^†

Neuralgia, Postherpetic

Intervention ^†

Drug: Placebo
Drug: Pregabalin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

372

Completion Date

November 2007

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Visual Analogue Scale (VAS) of pain is higher than 40 mm.
Pain is sustained for more than 3 months after healing of herpes zoster skin rash.

Exclusion Criteria:

Malignancy within the past 2 years.
Patients who have undergone neurolytic or neurosurgical therapy for postherpetic neuralgia.
Creatinine clearance </= 30 mL/min (estimated from serum creatinine, body weight, age, and sex using the Cockcroft and Gault equation, by omitting any decimal fractions).
Patients having other severe pain which may impair the self assessment of the pain due to postherpetic neuralgia.
Skin conditions in the affected dermatome that could alter sensation.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Japan

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00394901

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc.

Secondary IDs ^††

Study Sponsor ^†

Pfizer

Collaborators ^††

Investigators ^†

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

April 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.