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

NCT00654940 | Completed Phase 1 Results

• 1 other identifier: A0081187
• Study Type: interventional
• Target: 25
• Locations: 2 countries
• Sites: 5

Brief Summary

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

Conditions

Nerve Pain

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Treatment Week 2 in Daily Pain Rating Scale

  Daily Pain Rating Scale by treatment and sequence using an 11-point Likert scale: range 0 (no pain) to 10 (worst possible pain) over the past 24 hours. Self-assessment was performed daily on rising from bed (for the final time in the case of interrupted sleep). Average daily pain score: mean of the previous 7 days daily pain scores. Baseline was defined as the mean of the last 7 pre-treatment pain scores for each period. End of treatment was defined as the mean of the last 7 on treatment pain scores for each period.

  Week 0 to Week 2, Week 4 to Week 6 (Baseline to Week 2 [End of Treatment] for each treatment period)

Secondary Outcomes (2)

• Neuropathic Pain Symptom Inventory (NPSI)

  Week 0 to Week 2, Week 4 to Week 6 (Baseline to End of Treatment in Treatment Periods 1 and 2)

• Subject Activity as Captured by the Actiwatch Score Device: Total Activity Score at End of Treatment

  Week 0 to Week 2, Week 4 to Week 6 (Baseline to End of Treatment in Treatment Periods 1 and 2)

Study Arms (2)

A

ACTIVE COMPARATOR

Drug: Pregabalin (Lyrica)

B

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Pregabalin (Lyrica) DRUG

Oral, 75mg or 150mg capsules, BID

A

Placebo DRUG

Oral, matched capsules, BID

B

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (5)

Pfizer Investigational Site

Calgary, Alberta, T2N 4N1, Canada

Location

Pfizer Investigational Site

Hamilton, Ontario, L8N 3Z5, Canada

Location

Pfizer Investigational Site

Sarnia, Ontario, N7T 4X3, Canada

Location

Pfizer Investigational Site

Jönköping, 551 85, Sweden

Location

Pfizer Investigational Site

Linköping, 581 85, Sweden

Location

Related Links

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

MeSH Terms

Conditions

Neuralgia

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

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 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2008
• First Posted: April 9, 2008
• Study Start: May 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: February 9, 2021
• Results First Posted: February 24, 2010

Record last verified: 2010-02

Locations

CA (3); SE (2)