- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00629681
A Study of the Efficacy and Safety of Pregabalin for the Treatment of Diabetic Peripheral Neuropathy or Postherpetic Neuralgia
January 21, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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
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Aachen, Germany, 52064
- Pfizer Investigational Site
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Albstadt, Germany, 72458
- Pfizer Investigational Site
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Berlin, Germany, 10117
- Pfizer Investigational Site
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Berlin, Germany, 13053
- Pfizer Investigational Site
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Berlin, Germany, 10435
- Pfizer Investigational Site
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Bielefeld, Germany, 33604
- Pfizer Investigational Site
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Celle, Germany, 29221
- Pfizer Investigational Site
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Deggingen, Germany, 73326
- Pfizer Investigational Site
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Duisburg, Germany, 47051
- Pfizer Investigational Site
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Erbach, Germany, 64711
- Pfizer Investigational Site
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Erfurt, Germany, 99089
- Pfizer Investigational Site
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Frankfurt, Germany, 60311
- Pfizer Investigational Site
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Gera, Germany, 07548
- Pfizer Investigational Site
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Goeppingen, Germany, 73033
- Pfizer Investigational Site
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Hamburg, Germany, 21073
- Pfizer Investigational Site
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Hamburg, Germany, 22149
- Pfizer Investigational Site
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Hamburg, Germany, 22607
- Pfizer Investigational Site
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Hemsbach, Germany, 69502
- Pfizer Investigational Site
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Hildesheim, Germany, 31134
- Pfizer Investigational Site
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Holle, Germany, 31188
- Pfizer Investigational Site
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Itzehoe, Germany, 25524
- Pfizer Investigational Site
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Karlsruhe, Germany, 76199
- Pfizer Investigational Site
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Karlsruhe, Germany, 76133
- Pfizer Investigational Site
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Katzhuette, Germany, 98746
- Pfizer Investigational Site
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Leer, Germany, 26789
- Pfizer Investigational Site
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Leipzig, Germany, 04103
- Pfizer Investigational Site
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Limburgerhof, Germany, 67117
- Pfizer Investigational Site
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Ludwigshafen, Germany, 67069
- Pfizer Investigational Site
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Ludwigshafen, Germany, 67061
- Pfizer Investigational Site
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Luebeck, Germany, 23552
- Pfizer Investigational Site
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Luenen, Germany, 44534
- Pfizer Investigational Site
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Mainz, Germany, 55116
- Pfizer Investigational Site
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Marl, Germany, 45768
- Pfizer Investigational Site
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Muenchen, Germany, 81479
- Pfizer Investigational Site
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Muenster, Germany, 48129
- Pfizer Investigational Site
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Osnabrueck, Germany, 49078
- Pfizer Investigational Site
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Recklinghausen, Germany, 45657
- Pfizer Investigational Site
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Senftenberg, Germany, 01968
- Pfizer Investigational Site
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Sinsheim, Germany, 74889
- Pfizer Investigational Site
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Surwold, Germany, 26903
- Pfizer Investigational Site
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Unterhaching, Germany, 82008
- Pfizer Investigational Site
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Veitsbronn, Germany, 90587
- Pfizer Investigational Site
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Weimar, Germany, 99425
- Pfizer Investigational Site
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Wiesbaden, Germany, 65191
- Pfizer Investigational Site
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Witten, Germany, 58452
- Pfizer Investigational Site
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Zwoenitz, Germany, 08297
- Pfizer Investigational Site
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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 |
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Experimental: 1
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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
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Baseline to Week 4
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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
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14 and 7 days before baseline, baseline, and Days 4, 7, 14, and 28
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Change from baseline in mean sleep score from patient's daily sleep interference diary
Time Frame: End of treatment
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End of treatment
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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
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14 and 7 days before baseline, baseline, and Days 4, 7, 14, and 28
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Adverse events
Time Frame: 14 and 7 days before baseline, baseline, and Days 4, 7, 14, and 28
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14 and 7 days before baseline, baseline, and Days 4, 7, 14, and 28
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Change from baseline in Pain Treatment Satisfaction Scale (PTSS) 9 items score
Time Frame: End of treatment
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End of treatment
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Median time to pain response profile
Time Frame: Over the first week
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Over the first week
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CGIC and PGIC
Time Frame: End of treatment
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End of treatment
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Change from baseline in EuroQOL (as measures by EQ-5D)
Time Frame: End of treatment
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End of treatment
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Change from baseline in mean anxiety score from patient's daily anxiety diary
Time Frame: End of treatment
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End of treatment
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Change from baseline in Medical Outcomes Study (MOS)-Sleep Scale score
Time Frame: End of treatment
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End of treatment
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Course of mean pain score of patient's daily pain diary (NRS)
Time Frame: Throughout the study
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Throughout the study
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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
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Endocrine System Diseases
- Diabetes Complications
- Diabetes Mellitus
- Neuromuscular Diseases
- Neuralgia
- Peripheral Nervous System Diseases
- Diabetic Neuropathies
- Neuralgia, Postherpetic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Membrane Transport Modulators
- Anti-Anxiety Agents
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Pregabalin
Other Study ID Numbers
- A0081031
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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