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
1 other identifier
interventional
217
1 country
46
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2004
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 26, 2008
CompletedFirst Posted
Study publicly available on registry
March 6, 2008
CompletedJanuary 25, 2021
April 1, 2011
February 26, 2008
January 21, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (11)
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 sleep score from patient's daily sleep interference diary
End of treatment
Mean anxiety score from patient's daily anxiety diary
14 and 7 days before baseline, baseline, and Days 4, 7, 14, and 28
Adverse events
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
End of treatment
- +6 more secondary outcomes
Study Arms (1)
1
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- Diagnosis of DPN or PHN
- Score on the Numeric Rating Scale of at least 4/10
You may not qualify if:
- Hospitalized patients
- Neurologic disorders unrelated to DPN or PHN or any severe pain that may confound the assessment of DPN- or PHN-related pain
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (46)
Pfizer Investigational Site
Aachen, 52064, Germany
Pfizer Investigational Site
Albstadt, 72458, Germany
Pfizer Investigational Site
Berlin, 10117, Germany
Pfizer Investigational Site
Berlin, 10435, Germany
Pfizer Investigational Site
Berlin, 13053, Germany
Pfizer Investigational Site
Bielefeld, 33604, Germany
Pfizer Investigational Site
Celle, 29221, Germany
Pfizer Investigational Site
Deggingen, 73326, Germany
Pfizer Investigational Site
Duisburg, 47051, Germany
Pfizer Investigational Site
Erbach im Odenwald, 64711, Germany
Pfizer Investigational Site
Erfurt, 99089, Germany
Pfizer Investigational Site
Frankfurt, 60311, Germany
Pfizer Investigational Site
Gera, 07548, Germany
Pfizer Investigational Site
Göppingen, 73033, Germany
Pfizer Investigational Site
Hamburg, 21073, Germany
Pfizer Investigational Site
Hamburg, 22149, Germany
Pfizer Investigational Site
Hamburg, 22607, Germany
Pfizer Investigational Site
Hemsbach, 69502, Germany
Pfizer Investigational Site
Hildesheim, 31134, Germany
Pfizer Investigational Site
Holle, 31188, Germany
Pfizer Investigational Site
Itzehoe, 25524, Germany
Pfizer Investigational Site
Karlsruhe, 76133, Germany
Pfizer Investigational Site
Karlsruhe, 76199, Germany
Pfizer Investigational Site
Katzhütte, 98746, Germany
Pfizer Investigational Site
Leer, 26789, Germany
Pfizer Investigational Site
Leipzig, 04103, Germany
Pfizer Investigational Site
Limburgerhof, 67117, Germany
Pfizer Investigational Site
Ludwigshafen, 67061, Germany
Pfizer Investigational Site
Ludwigshafen, 67069, Germany
Pfizer Investigational Site
Lübeck, 23552, Germany
Pfizer Investigational Site
Lünen, 44534, Germany
Pfizer Investigational Site
Mainz, 55116, Germany
Pfizer Investigational Site
Marl, 45768, Germany
Pfizer Investigational Site
München, 81479, Germany
Pfizer Investigational Site
Münster, 48129, Germany
Pfizer Investigational Site
Osnabrück, 49078, Germany
Pfizer Investigational Site
Recklinghausen, 45657, Germany
Pfizer Investigational Site
Senftenberg, 01968, Germany
Pfizer Investigational Site
Sinsheim, 74889, Germany
Pfizer Investigational Site
Surwold, 26903, Germany
Pfizer Investigational Site
Unterhaching, 82008, Germany
Pfizer Investigational Site
Veitsbronn, 90587, Germany
Pfizer Investigational Site
Weimar, 99425, Germany
Pfizer Investigational Site
Wiesbaden, 65191, Germany
Pfizer Investigational Site
Witten, 58452, Germany
Pfizer Investigational Site
Zwönitz, 08297, Germany
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2008
First Posted
March 6, 2008
Study Start
November 1, 2004
Study Completion
February 1, 2006
Last Updated
January 25, 2021
Record last verified: 2011-04