Pregabalin Treatment Of Peripheral Neuropathic Pain Associated With Diabetic Peripheral NeP (DPN), Postherpetic Neuralgia (PHN), HIV-related NeP (HIV), and Chemotherapy Induced NeP

January 21, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

A Prospective, Open Label, Multi-Center, Study Of Pregabalin In The Treatment Of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy, Postherpetic Neuralgia, HIV-Related Peripheral Neuropathic Pain And Chemotherapy Induced Peripheral Neuropathic Pain

Management of neuropathic pain associated with diabetic peripheral neuropathy, post-herpetic neuralgia, human immunodeficiency virus-related peripheral neuropathy, and chemotherapy induced peripheral neuropathy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

121

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

  • Colombia
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia
        • Pfizer Investigational Site
  • Ecuador
    • Pichincha
      • Quito, Pichincha, Ecuador
        • Pfizer Investigational Site
  • Mexico
    • B. C.
      • Tijuana, B. C., Mexico, 22010
        • Pfizer Investigational Site
    • B.c.
      • Mexicali, B.c., Mexico, 21100
        • Pfizer Investigational Site
    • Distrito Federal
      • Mexico, Distrito Federal, Mexico, 14080
        • Pfizer Investigational Site
    • Guerrero
      • Acapulco, Guerrero, Mexico, 39670
        • Pfizer Investigational Site
    • Monterrey, NL
      • México, Monterrey, NL, Mexico, 64460
        • Pfizer Investigational Site
    • Yucatan
      • Merida, Yucatan, Mexico, 97000
        • Pfizer Investigational Site
  • Peru
      • Lima, Peru, 27
        • Pfizer Investigational Site
      • Lima, Peru, L13
        • Pfizer Investigational Site
  • Venezuela
    • Distrito Capital
      • Caracas, Distrito Capital, Venezuela, 1020
        • 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:

  • Patients who are diagnosed with neuropathic pain associated with diabetic peripheral neuropathy, post-herpetic neuralgia, human immunodeficiency virus related peripheral neuropathy, and chemotherapy induced peripheral neuropathy.

Exclusion Criteria:

  • Severe Pain associated with conditions other than Diabetic Peripheral Neuropathy, Post-Herpetic Neuralgia, Human Immunodeficiency virus related peripheral neuropathy, and chemotherapy induced peripheral neuropathy that may confound assessment or self evaluation of the neuropathic pain.
  • Skin Condition in the affected dermatome that (in the judgment of the investigator) could alter sensation.

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Pregabalin
Drug: Pregabalin
Pregabalin will be administered orally, twice a day for 12 weeks, including 4-week dose adjustment phase followed by 8-week maintenance phase. The minimum allowable pregabalin dose during the trial will be 75 mg BID (150 mg/day) and the maximum allowable dose will be 300 mg BID (600 mg/day).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to End of Treatment (EOT) in Weekly Mean Pain Score on the Daily Pain Rating Scale (DPRS)
Time Frame: Baseline, End of Treatment
11 point Likert scale: range 0 to 10 (no pain to worst possible pain) over past 24 hours. Baseline score = mean score of preceding 7 days (including Visit 2). Final end of treatment (EOT) pain score = mean pain score from last 7 post-Baseline days preceding Visit 8 (Week 12) or last 7 days on study drug for those who did not complete the study. Change = mean at EOT minus mean at Baseline.
Baseline, End of Treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS)
Time Frame: Week 4, Week 8, Week 12
11 point Likert scale; range: 0 to 10 (no pain to worst possible pain) over past 24 hours. Baseline score = mean score of preceding 7 days (including Visit 2). Weekly pain score = mean pain score from last 7 post-Baseline days preceding observation visit or last 7 days on study drug for early termination. Change = mean at observation minus mean at Baseline.
Week 4, Week 8, Week 12
Change From Baseline (BL) in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores
Time Frame: Baseline, Week 8, Week 12, EOT/LOCF
Self-administered questionnaire: change from Baseline in mean pain severity index over past 24 hours; 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst pain possible). Pain severity index is the mean of item scores 2, 3, and 4 (pain right now, worst pain, and average pain level). Change = mean score at observation minus mean score at Baseline.
Baseline, Week 8, Week 12, EOT/LOCF
Change From Baseline in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores
Time Frame: Baseline, Week 8, Week 12, End of Treatment/Last Observation Carried Forward (EOT/LOCF)
Self-administered questionnaire: change from Baseline in mean pain interference with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. 11-point scale from 0 (does not interfere) to 10 (completely interferes). Change = observation mean minus Baseline mean.
Baseline, Week 8, Week 12, End of Treatment/Last Observation Carried Forward (EOT/LOCF)
Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication
Time Frame: Baseline, Week 8, Week 12, EOT/LOCF
Impact of current pain medication response scale: 0 (worst possible response) to 100 (best possible response). Score=[(5-mean of non-missing items)*100]/4.
Baseline, Week 8, Week 12, EOT/LOCF
Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication
Time Frame: Baseline, Week 8, Week 12, EOT/LOCF
Satisfaction with current pain medication response scale: 0 (worst possible response) to 100 (best possible response). Score=[(5-mean of non-missing items)*100]/4.
Baseline, Week 8, Week 12, EOT/LOCF
Change From Baseline in Visual Analogue Scale for Pain (VAS-pain)
Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, EOT/LOCF
100 mm line (Visual Analog Scale) marked by subject; Intensity of pain range (over past week): 0 = no pain to 100 = worst possible pain. Change = observation mean minus Baseline mean.
Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, EOT/LOCF
Change From Baseline in Global Anxiety Visual Analogue Scale (GA-VAS)
Time Frame: Baseline, Week 8, Week 12, EOT/LOCF
100-mm line (Visual Analog Scale) marked by the subject to measure their degree of anxiety over past 24 hours. Range: 0 = not at all anxious to 100 = extremely anxious. Change = mean score at observation minus mean score at Baseline.
Baseline, Week 8, Week 12, EOT/LOCF
Change From Baseline in Mean Daily Sleep Interference Score (DSIS)
Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, EOT/LOCF
Daily sleep interference measured on an 11-point Likert scale. Range: 0 (pain did not interfere with sleep) to 10 (pain completely interfered with sleep). Change = mean at observation minus mean at Baseline. Evaluations recorded in patient's daily sleep diaries.
Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, EOT/LOCF
Patient Global Impression of Change (PGIC)
Time Frame: End of Treatment/ Last Observation Carried Forward (Week 12 or last post-baseline assessment)
7-point participant rating scale for change observed in their overall status since beginning of study medication. Range: 1 (very much improved) to 7 (very much worse)
End of Treatment/ Last Observation Carried Forward (Week 12 or last post-baseline assessment)
Clinical Global Impression of Change (CGIC)
Time Frame: End of Treatment/ Last Observation Carried Forward (Week 12 or last post-baseline assessment)
7-point investigator rating scale of change in participant's status since beginning study medication. Range: 1 (very much improved) to 7 (very much worse).
End of Treatment/ Last Observation Carried Forward (Week 12 or last post-baseline assessment)

Collaborators and Investigators

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

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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.

General Publications

Helpful Links

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

January 1, 2007

Primary Completion (ACTUAL)

July 1, 2008

Study Completion (ACTUAL)

July 1, 2008

Study Registration Dates

First Submitted

December 1, 2006

First Submitted That Met QC Criteria

December 1, 2006

First Posted (ESTIMATE)

December 5, 2006

Study Record Updates

Last Update Posted (ACTUAL)

February 9, 2021

Last Update Submitted That Met QC Criteria

January 21, 2021

Last Verified

October 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A0081097

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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