A Study To Assess The Ability Of A Crossover Study Design To Detect The Efficacy Of Pregabalin In Post-Traumatic Neuropathic Pain Patients

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00654940
First received: April 3, 2008
Last updated: February 8, 2010
Last verified: February 2010
  Purpose

The purpose of this study is to assess whether a cross-over type study design in post-traumatic neuropathic patients can be used to assess the activity of potential analgesic agents


Condition Intervention Phase
Nerve Pain
Drug: Pregabalin (Lyrica)
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Methodology Study To Assess The Ability Of A Randomized, Double-Blind, Placebo-Controlled, Two Period Crossover Study To Detect The Effect Of Pregabalin In Post-Traumatic Neuropathic Pain Patients

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change From Baseline to Treatment Week 2 in Daily Pain Rating Scale [ Time Frame: Week 0 to Week 2, Week 4 to Week 6 (Baseline to Week 2 [End of Treatment] for each treatment period) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neuropathic Pain Symptom Inventory (NPSI) [ Time Frame: Week 0 to Week 2, Week 4 to Week 6 (Baseline to End of Treatment in Treatment Periods 1 and 2) ] [ Designated as safety issue: No ]
  • Subject Activity as Captured by the Actiwatch Score Device: Total Activity Score at End of Treatment [ Time Frame: Week 0 to Week 2, Week 4 to Week 6 (Baseline to End of Treatment in Treatment Periods 1 and 2) ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: May 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: Pregabalin (Lyrica)
Oral, 75mg or 150mg capsules, BID
Placebo Comparator: B Drug: Placebo
Oral, matched capsules, BID

Detailed Description:

Methodology study to evaluate a cross-over study design in post-traumatic neuropathic pain patients.

  Eligibility

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

Inclusion Criteria:

  • Patients require a diagnosis of post-traumatic peripheral neuropathic pain (NeP), including post-surgical NeP and NeP due to peripheral nerve injury, which has lasted at least 3 months following the traumatic event.
  • Patients during the screening week must have completed ≥ 4 daily pain scores and have an average daily pain score ≥ 4.
  • Female patients of childbearing potential must have a negative urine pregnancy test at Screening and be practicing an acceptable form of contraception.

Exclusion Criteria:

  • Patients with neuropathic pain (NeP) that is not due to trauma; e.g. patients with trigeminal neuralgia, central pain, complex region pain syndrome type I, phantom limb pain, radiculopathy, painful diabetic neuropathy or post-herpetic neuralgia or patients with any other co-existing pain which cannot be differentiate from NeP of peripheral origin.
  • Patients who have previously failed to respond to pregabalin at a total daily dose of equal to or greater than 300 mg or are intolerant to those doses.
  • Patients who have previously failed to respond to gabapentin at a total daily dose of equal to or greater than 1800 mg.
  • Patients with any type or history of malignancy, except either where there has been no ongoing treatment for at least 6 months or all basal cell carcinomas; all patients with a history of brain or spinal tumors will be excluded.
  • Patients who currently have ongoing litigation related to any injury affecting their pain symptomatology.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00654940

Locations
Canada, Alberta
Pfizer Investigational Site
Calgary, Alberta, Canada, T2N 4N1
Canada, Ontario
Pfizer Investigational Site
Hamilton, Ontario, Canada, L8N 3Z5
Pfizer Investigational Site
Sarnia, Ontario, Canada, N7T 4X3
Sweden
Pfizer Investigational Site
Jonkoping, Sweden, 551 85
Pfizer Investigational Site
Linkoping, Sweden, 581 85
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00654940     History of Changes
Other Study ID Numbers: A0081187
Study First Received: April 3, 2008
Results First Received: January 5, 2010
Last Updated: February 8, 2010
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on July 23, 2014