A Study of the Efficacy and Safety of Pregabalin for the Treatment of Diabetic Peripheral Neuropathy or Postherpetic Neuralgia

Phase 4

Completed

• Conditions: Painful Diabetic Neuropathy and Post Herpetic Neuralgia
• Interventions: Drug: Pregabalin

• Registration Number: NCT00629681
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

The purpose of this study is to assess the efficacy and safety of pregabalin for the treatment of diabetic peripheral neuropathy (DPN) or postherpetic neuralgia (PHN)

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11
• Study Completion: 2006-02
• Study First Submitted: 2008-02-26
• Study First Submitted QC: 2008-02-26
• Study First Posted: 2008-03-06
• Status Verified: 2011-04
• Last Update Submitted: 2021-01-21
• Last Update Posted: 2021-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 217

Inclusion Criteria

Not provided

Exclusion Criteria

• Hospitalized patients
• Neurologic disorders unrelated to DPN or PHN or any severe pain that may confound the assessment of DPN- or PHN-related pain

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Pregabalin	-

Primary Outcome Measures

Name	Time	Method
Correlation between global status (as measured by the Clinical Global Impression of Change [CGIC] and the Patient Global Impression of Change [PGIC]) and changes in pain, anxiety, and sleep parameters	Baseline to Week 4

Secondary Outcome Measures

Name	Time	Method
Mean anxiety score from patient's daily anxiety diary	14 and 7 days before baseline, baseline, and Days 4, 7, 14, and 28
CGIC and PGIC	End of treatment
Course of mean pain score of patient's daily pain diary (NRS)	Throughout the study
Adverse events	14 and 7 days before baseline, baseline, and Days 4, 7, 14, and 28
Change from baseline in EuroQOL (as measures by EQ-5D)	End of treatment
Mean sleep score from patient's daily sleep interference diary	14 and 7 days before baseline, baseline, and Days 4, 7, 14, and 28
Change from baseline in mean anxiety score from patient's daily anxiety diary	End of treatment
Change from baseline in Medical Outcomes Study (MOS)-Sleep Scale score	End of treatment
Change from baseline in mean sleep score from patient's daily sleep interference diary	End of treatment
Change from baseline in Pain Treatment Satisfaction Scale (PTSS) 9 items score	End of treatment
Median time to pain response profile	Over the first week

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇩🇪 Zwoenitz, Germany