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Effect Of Pregabalin Treatmen...

Effect Of Pregabalin Treatment In Patients With Diabetic Nerve Pain Who Currently Use A Non-Steroid Anti-Inflammatory Drug (NSAID) For Another Pain

Last Updated: 2021-01-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

306 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-12-31

Brief Summary

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This study is to test the effectiveness of pregabalin in treating nerve pain caused by diabetes. The suitable subjects will be patients who also use an non-steroid anti-inflammatory drug for another pain which is not related to the diabetic nerve pain.

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Detailed Description

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Conditions

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Painful Diabetic Peripheral Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1: Pregabalin

Group Type EXPERIMENTAL

pregabalin

Intervention Type DRUG

150 - 300 mg/day in divided dose (3 time a day) for 6 weeks

2: Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

matching placebo 3 time a day

Interventions

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pregabalin

150 - 300 mg/day in divided dose (3 time a day) for 6 weeks

Intervention Type DRUG

placebo

matching placebo 3 time a day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Type 1 or 2 diabetes with painful neuropathy
* Currently treated with one NSAID (including COX 2 inhibitors) for a co morbid pain condition with a regular dose
* Meet pre-defined level of pain severity at entrance

Exclusion Criteria

* History of failed pregabalin treatment due to lack of efficacy at therapeutic dose
* Participated in a previous or ongoing pregabalin clinical trial
* Neurologic disorders unrelated to diabetic neuropathy that may confound the assessment of distal neuropathic pain

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

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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