A Study of the Efficacy and Safety of Pregabalin for the Treatment of Diabetic Peripheral Neuropathy or Postherpetic Neuralgia
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00629681
First received: February 26, 2008
Last updated: April 22, 2011
Last verified: April 2011
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Purpose
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)
| Condition | Intervention | Phase |
|---|---|---|
|
Painful Diabetic Neuropathy and Post Herpetic Neuralgia |
Drug: Pregabalin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Efficacy and Safety of Pregabalin in an Open-label, Non-comparative, Flexible-dose Trial With Diabetic Peripheral Neuropathy or Postherpetic Neuralgia |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- Change from baseline in mean sleep score from patient's daily sleep interference diary [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Adverse events [ Time Frame: 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 ] [ Designated as safety issue: No ]
- Median time to pain response profile [ Time Frame: Over the first week ] [ Designated as safety issue: No ]
- CGIC and PGIC [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
- Change from baseline in EuroQOL (as measures by EQ-5D) [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
- Change from baseline in mean anxiety score from patient's daily anxiety diary [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
- Change from baseline in Medical Outcomes Study (MOS)-Sleep Scale score [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
- Course of mean pain score of patient's daily pain diary (NRS) [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
| Enrollment: | 217 |
| Study Start Date: | November 2004 |
| Study Completion Date: | February 2006 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Pregabalin
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00629681
Locations
| Germany | |
| Pfizer Investigational Site | |
| Aachen, Germany, 52064 | |
| Pfizer Investigational Site | |
| Albstadt, Germany, 72458 | |
| Pfizer Investigational Site | |
| Berlin, Germany, 10435 | |
| Pfizer Investigational Site | |
| Berlin, Germany, 10117 | |
| Pfizer Investigational Site | |
| Berlin, Germany, 13053 | |
| 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, 22149 | |
| Pfizer Investigational Site | |
| Hamburg, Germany, 22607 | |
| Pfizer Investigational Site | |
| Hamburg, Germany, 21073 | |
| 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 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00629681 History of Changes |
| Other Study ID Numbers: | A0081031 |
| Study First Received: | February 26, 2008 |
| Last Updated: | April 22, 2011 |
| Health Authority: | Germany: Landesamt für Gesundheit und Arbeitssicherheit des Landes Schleswig-Holstein |
Additional relevant MeSH terms:
|
Diabetic Neuropathies Neuralgia Peripheral Nervous System Diseases Neuralgia, Postherpetic Neuromuscular Diseases Nervous System Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Pain Neurologic Manifestations |
Signs and Symptoms Pregabalin Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anticonvulsants |
ClinicalTrials.gov processed this record on May 22, 2013