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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00629681

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
Neuralgia, Postherpetic Diabetic Neuropathies	Drug: Pregabalin	Phase IV

MedlinePlus related topics: Anxiety Diabetic Nerve Problems Peripheral Nerve Disorders Shingles

Drug Information available for: Pregabalin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Efficacy and Safety of Pregabalin in an Open-Label, Non-Comparative, Flexible-Dose Trial With Diabetic Peripheral Neuropathy or Postherpetic Neuralgia

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 ]

Estimated Enrollment:	300
Study Start Date:	November 2004
Study Completion Date:	February 2006

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

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A0081031
Study First Received:	February 26, 2008
Last Updated:	April 23, 2008
ClinicalTrials.gov Identifier:	NCT00629681
Health Authority:	Germany: Landesamt für Gesundheit und Arbeitssicherheit des Landes Schleswig-Holstein

Study placed in the following topic categories:

Neuralgia, Postherpetic
Diabetic Neuropathies
Neuralgia
Diabetes Mellitus
Endocrine System Diseases
Pregabalin
Pain

Signs and Symptoms
Neuromuscular Diseases
Peripheral Nervous System Diseases
Neurologic Manifestations
Endocrinopathy
Diabetes Complications

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Peripheral Nervous System Agents

Analgesics
Central Nervous System Agents
Anticonvulsants
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009