Study of Pregabalin Therapy for Pain Relief in Subjects With Post-Herpetic Neuralgia

NCT ID: NCT00159666

Last Updated: 2021-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

255 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2006-06-30

Brief Summary

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The purpose of this study is to measure how rapidly pregabalin treatment can relieve pain in patients with post-herpetic neuralgia

Detailed Description

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Conditions

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Post-Herpetic Neuralgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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pregabalin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of PHN with pain present for at least three months after the healing of a Herpes Zoster skin lesion.
* Subjects must have completed the Daily Pain Rating Scale in the electronic diary at least 4 times during screening and have an average daily pain rating score of greater than or equl to 4 during the 7 +/- 3 days prior to randomization (Visit 2).

Exclusion Criteria

* History of neurolytic or neurosurgical therapy for PHN.
* Presence of any severe pain associated with conditions other than PHN that may confound the assessment or self-evaluation of the pain due to PHN.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Phoenix, Arizona, United States

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Little Rock, Arkansas, United States

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Duarte, California, United States

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Denver, Colorado, United States

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Palm Beach Gardens, Florida, United States

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Oak Brook, Illinois, United States

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Flowood, Mississippi, United States

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St Louis, Missouri, United States

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Toledo, Ohio, United States

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Portland, Oregon, United States

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Allentown, Pennsylvania, United States

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Houston, Texas, United States

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Seattle, Washington, United States

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Madison, Wisconsin, United States

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Berlin, , Germany

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Bochum, , Germany

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Düsseldorf, , Germany

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Frankfurt, , Germany

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Göppingen, , Germany

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Hamburg, , Germany

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Hattingen, , Germany

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Jena, , Germany

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Nuremberg, , Germany

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Wiesbaden, , Germany

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L’Aquila, , Italy

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Perugia, , Italy

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Pisa, , Italy

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Roma, , Italy

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Leganés, Madrid, Spain

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Barcelona, , Spain

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Granada, , Spain

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Salamanca, , Spain

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Seville, , Spain

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Valencia, , Spain

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Middlesbrough, Cleveland, United Kingdom

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Addlestone, Surrey, United Kingdom

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Chicester, Sussex, United Kingdom

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Glasgow, , United Kingdom

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Oldham, Lancashire, , United Kingdom

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Portsmouth, , United Kingdom

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Countries

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United States Germany Italy Spain United Kingdom

References

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Schug SA, Parsons B, Almas M, Whalen E. Effect of Concomitant Pain Medications on Response to Pregabalin in Patients with Postherpetic Neuralgia or Spinal Cord Injury-Related Neuropathic Pain. Pain Physician. 2017 Jan-Feb;20(1):E53-E63.

Reference Type DERIVED
PMID: 28072797 (View on PubMed)

Markman JD, Jensen TS, Semel D, Li C, Parsons B, Behar R, Sadosky AB. Effects of Pregabalin in Patients with Neuropathic Pain Previously Treated with Gabapentin: A Pooled Analysis of Parallel-Group, Randomized, Placebo-controlled Clinical Trials. Pain Pract. 2017 Jul;17(6):718-728. doi: 10.1111/papr.12516. Epub 2016 Dec 1.

Reference Type DERIVED
PMID: 27611736 (View on PubMed)

Related Links

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Other Identifiers

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A0081004

Identifier Type: -

Identifier Source: org_study_id

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