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P4 (Pregabalin for Peripheral Posttraumatic Pain)
This study has been completed.
Sponsored by: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00292188
  Purpose

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


Condition Intervention Phase
Neuralgia
 Drug: pregabalin
Drug: Placebo
 Phase IV

Drug Information available for: Pregabalin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title: A 9 Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Study Of Pregabalin (BID) In Subject With Posttraumatic Peripheral Neuropathic Pain

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Weekly Mean Pain Score at Week 8 (or early termination, last observation carried forward [LOCF]) from Daily Pain Diary [ Time Frame: 9 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self-reported sleep quality using Medical Outcome Study (MOS) Sleep Scale (1-Week Recall Period) [ Time Frame: 9 Weeks ] [ Designated as safety issue: No ]
  • Subject's global impression of change using the Patient Global Impression of Change (PGIC) [ Time Frame: 9 Weeks ] [ Designated as safety issue: No ]
  • Investigator's global impression using the clinician-rate scale - Clinical Global Impression of Change (CGIC) [ Time Frame: 9 Weeks ] [ Designated as safety issue: No ]
  • Pain Treatment Satisfaction Scale (PTSS) [ Time Frame: 9 Weeks ] [ Designated as safety issue: No ]
  • Modified Brief Pain Inventory Shrot Form (m-BPI-sf) [ Time Frame: 9 Weeks ] [ Designated as safety issue: No ]
  • Neuropathic Pain Symptom Inventory (NPSI) [ Time Frame: 9 Weeks ] [ Designated as safety issue: No ]
  • MOS cognitive subscale (MOS-cog; 1-week recall period) [ Time Frame: 9 Weeks ] [ Designated as safety issue: No ]
  • Davidson Trauma Scale (DTS) [ Time Frame: 9 Weeks ] [ Designated as safety issue: No ]
  • Hospital Anxiety and Depression Scale (HADS) Anxiety sub-scale score [ Time Frame: 9 Weeks ] [ Designated as safety issue: No ]
  • Hospital Anxiety and Depression Scale (HADS) Depression sub-scale score [ Time Frame: 9 Weeks ] [ Designated as safety issue: No ]
  • Weekly Mean Pain Score from Daily Pain Diary [ Time Frame: 9 Weeks ] [ Designated as safety issue: No ]
  • Weekly Mean Sleep Interference Score from Daily Sleep Dairy [ Time Frame: 9 Weeks ] [ Designated as safety issue: No ]

Enrollment: 255
Study Start Date: January 2006
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active: Experimental Drug: pregabalin
pregabalin
Placebo: Placebo Comparator Drug: Placebo
placebo

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00292188

  Show 44 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

Responsible Party: Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers: A0081064
Study First Received: February 13, 2006
Last Updated: September 24, 2008
ClinicalTrials.gov Identifier: NCT00292188  
Health Authority: United Kingdom: Department of Health

Keywords provided by Pfizer:
Phase 4, post-traumatic neuropathic pain, neuropathic pain, Nep, post surgical pain, nerve injury, phantom limb pain, international

Study placed in the following topic categories:
Signs and Symptoms
Neuromuscular Diseases
Neuralgia
Peripheral Nervous System Diseases
 Pregabalin
Neurologic Manifestations
Pain
Phantom Limb

Additional relevant MeSH terms:
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Peripheral Nervous System Agents
 Analgesics
Central Nervous System Agents
Anticonvulsants
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009



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