Study to Determine if a Reduction in Pain Can be Measured in Spinal Cord Injured Patients Using a New Study Design

NCT00978341 | Terminated Results DMC

• 1 other identifier: A0081141
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 4

Brief Summary

The study is designed to assess if spinal cord injury patients have reduced pain after taking either pregabalin or placebo in a cross over design. Patients had either pain at the level of their injury or below the level of their injury.

Conditions

Spinal Cord Injuries

Keywords

Clinical Trial Methodology study Neuropathic pain in Spinal cord injury patients Pain endpoints Crossover design

Outcome Measures

Primary Outcomes (1)

• Present Pain Intensity Score

  Present pain intensity score: 0-10 numeric rating scale (NRS), 0 (no pain) to 10 (worst possible pain).

  Day 1: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours (post-dose); Day 8: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours (post-dose)

Secondary Outcomes (7)

• Daily Pain Score

  Predose: Daily from 7 days before Visit 2 (start of Intervention 1) until the morning of Visit 5 (end of Intervention 2)

• Dynamic Allodynia Area

  Screening, Days 1 & 8: 0 (pre-dose) & 4 hours post-dose,

• Dynamic Allodynia Pain Score

  Screening, Days 1 & 8: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, and 6 hours post-dose

• Punctate Allodynia Area

  Screening, Days 1 & 8: 0 (pre-dose) and 4 hours post-dose

• Mechanical Pain Sensitivity Stimulus-Response Function

  Screening, Days 1 & 8: 0 (pre-dose), & 2, 4, and 6 hours post-dose

Study Arms (2)

Pregabalin

EXPERIMENTAL

Drug: Pregabalin

Placebo

OTHER

Drug: Placebo for pregabalin

Interventions

Pregabalin DRUG

Pregabalin 150mg capsules BID for 7.5 days

Pregabalin

Placebo for pregabalin DRUG

Placebo capsules BID for 7.5 days

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• subjects who are outpatients or inpatients
• written informed consent obtained (signed by the subject or the subject's legally acceptable representative)
• traumatic spinal cord injury of at least 1 year duration with a nonprogressive, i.e., chronic, stage of at least 6 months duration
• At-level neuropathic pain: spontaneous or evoked pain with neuropathic features (sharp, shooting, electric or burning pain sensation) in the region of sensory disturbance in a segmental pattern and located within two dermatomes above or below the level of spinal cord injury
• Below-level neuropathic pain: spontaneous or evoked pain with neuropathic features (sharp, shooting, electric or burning pain sensation) in the region of sensory disturbance located at least three dermatomes below the level of spinal cord injury

You may not qualify if:

• spinal cord injury (subjects with central pain and musculoskeletal pain must be able to make a distinction between the two)
• subjects who have previously not responded to 300 mg/day pregabalin: a non-responder is defined as a subject who has a reduction in pain score of less than 30% from baseline

Sponsors & Collaborators

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

Study Sites (4)

Pfizer Investigational Site

Randwick, New South Wales, 2031, Australia

Location

Pfizer Investigational Site

St Leonards, New South Wales, 2065, Australia

Location

Pfizer Investigational Site

Warrawong, New South Wales, 2502, Australia

Location

Pfizer Investigational Site

Heidelberg, Victoria, 3084, Australia

Location

Related Links

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

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

This study was terminated prematurely.

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: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2009
• First Posted: September 16, 2009
• Study Start: February 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: January 25, 2021
• Results First Posted: November 9, 2009

Record last verified: 2010-01

Locations

AU (4)