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

Efficacy and Safety of Pregabalin in an Open-label, Non-comparative, Flexible-dose Trial With Diabetic Peripheral Neuropathy or Postherpetic Neuralgia

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)

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

217

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Aachen, Germany, 52064
        • Pfizer Investigational Site
      • Albstadt, Germany, 72458
        • Pfizer Investigational Site
      • Berlin, Germany, 10117
        • Pfizer Investigational Site
      • Berlin, Germany, 13053
        • Pfizer Investigational Site
      • Berlin, Germany, 10435
        • Pfizer Investigational Site
      • Bielefeld, Germany, 33604
        • Pfizer Investigational Site
      • Celle, Germany, 29221
        • Pfizer Investigational Site
      • Deggingen, Germany, 73326
        • Pfizer Investigational Site
      • Duisburg, Germany, 47051
        • Pfizer Investigational Site
      • Erbach, Germany, 64711
        • Pfizer Investigational Site
      • Erfurt, Germany, 99089
        • Pfizer Investigational Site
      • Frankfurt, Germany, 60311
        • Pfizer Investigational Site
      • Gera, Germany, 07548
        • Pfizer Investigational Site
      • Goeppingen, Germany, 73033
        • Pfizer Investigational Site
      • Hamburg, Germany, 21073
        • Pfizer Investigational Site
      • Hamburg, Germany, 22149
        • Pfizer Investigational Site
      • Hamburg, Germany, 22607
        • Pfizer Investigational Site
      • Hemsbach, Germany, 69502
        • Pfizer Investigational Site
      • Hildesheim, Germany, 31134
        • Pfizer Investigational Site
      • Holle, Germany, 31188
        • Pfizer Investigational Site
      • Itzehoe, Germany, 25524
        • Pfizer Investigational Site
      • Karlsruhe, Germany, 76199
        • Pfizer Investigational Site
      • Karlsruhe, Germany, 76133
        • Pfizer Investigational Site
      • Katzhuette, Germany, 98746
        • Pfizer Investigational Site
      • Leer, Germany, 26789
        • Pfizer Investigational Site
      • Leipzig, Germany, 04103
        • Pfizer Investigational Site
      • Limburgerhof, Germany, 67117
        • Pfizer Investigational Site
      • Ludwigshafen, Germany, 67069
        • Pfizer Investigational Site
      • Ludwigshafen, Germany, 67061
        • Pfizer Investigational Site
      • Luebeck, Germany, 23552
        • Pfizer Investigational Site
      • Luenen, Germany, 44534
        • Pfizer Investigational Site
      • Mainz, Germany, 55116
        • Pfizer Investigational Site
      • Marl, Germany, 45768
        • Pfizer Investigational Site
      • Muenchen, Germany, 81479
        • Pfizer Investigational Site
      • Muenster, Germany, 48129
        • Pfizer Investigational Site
      • Osnabrueck, Germany, 49078
        • Pfizer Investigational Site
      • Recklinghausen, Germany, 45657
        • Pfizer Investigational Site
      • Senftenberg, Germany, 01968
        • Pfizer Investigational Site
      • Sinsheim, Germany, 74889
        • Pfizer Investigational Site
      • Surwold, Germany, 26903
        • Pfizer Investigational Site
      • Unterhaching, Germany, 82008
        • Pfizer Investigational Site
      • Veitsbronn, Germany, 90587
        • Pfizer Investigational Site
      • Weimar, Germany, 99425
        • Pfizer Investigational Site
      • Wiesbaden, Germany, 65191
        • Pfizer Investigational Site
      • Witten, Germany, 58452
        • Pfizer Investigational Site
      • Zwoenitz, Germany, 08297
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Diagnosis of DPN or PHN
  • Score on the Numeric Rating Scale of at least 4/10

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Pregabalin capsules; initial dose of 75 mg twice daily for 4 days. Dose could be increased based on individual patient's response and tolerability to 150 mg twice daily from Day 4 onwards, with a further increase to 300 mg twice daily from Day 14 onwards if needed. Total duration of treatment was 28 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: Baseline to Week 4
Baseline to Week 4

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Study Completion (Actual)

February 1, 2006

Study Registration Dates

First Submitted

February 26, 2008

First Submitted That Met QC Criteria

February 26, 2008

First Posted (Estimate)

March 6, 2008

Study Record Updates

Last Update Posted (Actual)

January 25, 2021

Last Update Submitted That Met QC Criteria

January 21, 2021

Last Verified

April 1, 2011

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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