P4 (Pregabalin for Peripheral Posttraumatic Pain)

NCT ID: NCT00292188

Last Updated: 2021-02-09

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

PHASE4

Total Enrollment

255 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-05-31

Brief Summary

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To evaluate the efficacy of pregabalin compared to placebo in the treatment of posttraumatic peripheral neuropathic pain

Detailed Description

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Conditions

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Neuralgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active

Group Type EXPERIMENTAL

pregabalin

Intervention Type DRUG

pregabalin

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo

Interventions

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pregabalin

pregabalin

Intervention Type DRUG

Placebo

placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Posttraumatic Peripheral Neuropathic Pain (NeP) syndrome, including post-surgical NeP, NeP due to peripheral nerve injury, and phantom limb pain, confirmed by a qualified pain specialist and persisting for a minimum of 3 months following the traumatic event

Exclusion Criteria

* Subjects whose posttraumatic neuropathic pain is due to Complex Regional Pain Syndrome (CRPS, Type I or Type II)
* NeP not due to trauma, and not peripheral pain
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 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

Brussels, , Belgium

Site Status

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Genk, , Belgium

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Liège, , Belgium

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Liège, , Belgium

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Pellenberg, , Belgium

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Wilrijk, , Belgium

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Calgary, Alberta, Canada

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Vancouver, British Columbia, Canada

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Sarnia, Ontario, Canada

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Toronto, Ontario, Canada

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Aarhus C, , Denmark

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Hvidovre, , Denmark

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HUS, , Finland

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Tampere, , Finland

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Milan, , Italy

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Montescano (PV), , Italy

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Roma, , Italy

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Tilburg, North Brabant, Netherlands

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Amsterdam, North Holland, Netherlands

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Alkmaar, , Netherlands

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Breda, , Netherlands

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Kampen, , Netherlands

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Roosendaal, , Netherlands

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Almada, , Portugal

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Amadora, , Portugal

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Coimbra, , Portugal

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Funchal, , Portugal

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Guimarães, , Portugal

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Lisbon, , Portugal

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Lisbon, , Portugal

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Porto, , Portugal

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Iași, , Romania

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Linköping, , Sweden

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Lund, , Sweden

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Stockholm, , Sweden

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Bern, , Switzerland

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Geneva, , Switzerland

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Birmingham, , United Kingdom

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Glasgow, , United Kingdom

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Leeds, , United Kingdom

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Plymouth, , United Kingdom

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Countries

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Belgium Canada Denmark Finland Italy Netherlands Portugal Romania Sweden Switzerland United Kingdom

References

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van Seventer R, Serpell M, Bach FW, Morlion B, Zlateva G, Bushmakin AG, Cappelleri JC, Nimour M. Relationships between changes in pain severity and other patient-reported outcomes: an analysis in patients with posttraumatic peripheral neuropathic pain. Health Qual Life Outcomes. 2011 Mar 25;9:17. doi: 10.1186/1477-7525-9-17.

Reference Type DERIVED
PMID: 21439051 (View on PubMed)

Related Links

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Other Identifiers

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A0081064

Identifier Type: -

Identifier Source: org_study_id

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