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

NCT ID: NCT00629681

Last Updated: 2021-01-25

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

217 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2006-02-28

Brief Summary

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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)

Detailed Description

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Conditions

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Painful Diabetic Neuropathy and Post Herpetic Neuralgia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Pregabalin

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
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

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Aachen, , Germany

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Albstadt, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Bielefeld, , Germany

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Celle, , Germany

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Deggingen, , Germany

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Duisburg, , Germany

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Erbach im Odenwald, , Germany

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Erfurt, , Germany

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Frankfurt, , Germany

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Gera, , Germany

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Göppingen, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

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Hemsbach, , Germany

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Hildesheim, , Germany

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Holle, , Germany

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Itzehoe, , Germany

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Karlsruhe, , Germany

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Karlsruhe, , Germany

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Katzhütte, , Germany

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Leer, , Germany

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Leipzig, , Germany

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Limburgerhof, , Germany

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Ludwigshafen, , Germany

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Ludwigshafen, , Germany

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Lübeck, , Germany

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Lünen, , Germany

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Mainz, , Germany

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Marl, , Germany

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München, , Germany

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Münster, , Germany

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Osnabrück, , Germany

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Recklinghausen, , Germany

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Senftenberg, , Germany

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Sinsheim, , Germany

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Surwold, , Germany

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Unterhaching, , Germany

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Veitsbronn, , Germany

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Weimar, , Germany

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Wiesbaden, , Germany

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Witten, , Germany

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Zwönitz, , Germany

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Countries

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Germany

Related Links

Other Identifiers

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A0081031

Identifier Type: -

Identifier Source: org_study_id

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