P4 (Pregabalin for Peripheral Posttraumatic Pain)

NCT00292188 | Completed Phase 4 Results

• 1 other identifier: A0081064
• Study Type: interventional
• Target: 255
• Locations: 11 countries
• Sites: 44

Brief Summary

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

Conditions

Neuralgia

Keywords

Phase 4, post-traumatic neuropathic pain, neuropathic pain, Nep, post surgical pain, nerve injury, phantom limb pain, international

Outcome Measures

Primary Outcomes (1)

• Weekly Mean Pain Score at End of Treatment (Week 8) From Daily Pain Diary

  Daily Pain Diary scale : mean score from 11-point numerical scale of pain; range: 0 (no pain) to 10 (worst possible pain). Endpoint weekly mean pain score: mean of the last 7 available pain scores from a daily pain diary during double blind treatment.

  each day of Week 8

Secondary Outcomes (26)

• Hospital Anxiety and Depression Scale (HADS) Anxiety Score

  Week 8

• Hospital Anxiety and Depression Scale (HADS) Depression Score

  Week 8

• Hospital Anxiety and Depression Scale (HADS) Anxiety Score - FAS Subset With Moderate/Severe Baseline Scores

  Week 8

• Hospital Anxiety and Depression Scale (HADS) Depression Score - FAS Subset With Moderate/Severe Baseline Scores

  Week 8

• Weekly Mean Pain Score From Daily Pain Diary

  Baseline through Week 8

Study Arms (2)

Active

EXPERIMENTAL

Drug: pregabalin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

pregabalin DRUG

pregabalin

Active

Placebo DRUG

placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (44)

Pfizer Investigational Site

Brussels, 1070, Belgium

Location

Pfizer Investigational Site

Genk, B-3600, Belgium

Location

Pfizer Investigational Site

Liège, 4020, Belgium

Location

Pfizer Investigational Site

Liège, B-4000, Belgium

Location

Pfizer Investigational Site

Pellenberg, B-3212, Belgium

Location

Pfizer Investigational Site

Wilrijk, B-2610, Belgium

Location

Pfizer Investigational Site

Calgary, Alberta, T2N 4N1, Canada

Location

Pfizer Investigational Site

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Pfizer Investigational Site

Sarnia, Ontario, N7T 4X3, Canada

Location

Pfizer Investigational Site

Toronto, Ontario, M5G 1X5, Canada

Location

Pfizer Investigational Site

Aarhus C, 8000, Denmark

Location

Pfizer Investigational Site

Hvidovre, 2650, Denmark

Location

Pfizer Investigational Site

HUS, 00029, Finland

Location

Pfizer Investigational Site

Tampere, 33520, Finland

Location

Pfizer Investigational Site

Milan, 20127, Italy

Location

Pfizer Investigational Site

Montescano (PV), 27040, Italy

Location

Pfizer Investigational Site

Roma, 00133, Italy

Location

Pfizer Investigational Site

Tilburg, North Brabant, 5022 GC, Netherlands

Location

Pfizer Investigational Site

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Pfizer Investigational Site

Alkmaar, 1815 JD, Netherlands

Location

Pfizer Investigational Site

Breda, 4819 EV, Netherlands

Location

Pfizer Investigational Site

Kampen, 8266 AB, Netherlands

Location

Pfizer Investigational Site

Roosendaal, 4708 AE, Netherlands

Location

Pfizer Investigational Site

Almada, 2801-951, Portugal

Location

Pfizer Investigational Site

Amadora, 2720-276, Portugal

Location

Pfizer Investigational Site

Coimbra, 3000-075, Portugal

Location

Pfizer Investigational Site

Funchal, 9004-514, Portugal

Location

Pfizer Investigational Site

Guimarães, 4800-055, Portugal

Location

Pfizer Investigational Site

Lisbon, 1169-050, Portugal

Location

Pfizer Investigational Site

Lisbon, 1649-035, Portugal

Location

Pfizer Investigational Site

Porto, 4099-001, Portugal

Location

Pfizer Investigational Site

Bucharest, 021155, Romania

Location

Pfizer Investigational Site

Bucharest, 050098, Romania

Location

Pfizer Investigational Site

Bucharest, 76251, Romania

Location

Pfizer Investigational Site

Iași, 700661, Romania

Location

Pfizer Investigational Site

Linköping, 581 85, Sweden

Location

Pfizer Investigational Site

Lund, SE-22185, Sweden

Location

Pfizer Investigational Site

Stockholm, 171 76, Sweden

Location

Pfizer Investigational Site

Bern, CH-3010, Switzerland

Location

Pfizer Investigational Site

Geneva, CH-1211, Switzerland

Location

Pfizer Investigational Site

Birmingham, B29 6JD, United Kingdom

Location

Pfizer Investigational Site

Glasgow, G12 0YN, United Kingdom

Location

Pfizer Investigational Site

Leeds, LS14 6UH, United Kingdom

Location

Pfizer Investigational Site

Plymouth, PL6 8DH, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 21439051 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Neuralgia; Pain, Postoperative; Phantom Limb

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Perceptual Disorders; Neurobehavioral Manifestations

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2006
• First Posted: February 15, 2006
• Study Start: January 1, 2006
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: February 9, 2021
• Results First Posted: October 5, 2009

Record last verified: 2011-04

Locations

CA (4); DK (2); CH (2); IT (3); FI (2); RO (4); GB (4); NL (6); PT (8); SE (3); BE (6)