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

Information source: Pfizer
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Nerve Pain

Intervention: Pregabalin (Lyrica) (Drug); Placebo (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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

Clinical Details

Official title: Methodology Study To Assess The Ability Of A Randomized, Double-Blind, Placebo-Controlled, Two Period Crossover Study To Detect The Efficacy Of Pregabalin In Post-Traumatic Neuropathic Pain Patients

Study design: Other, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Efficacy Study

Primary outcome: Numerical daily pain score (using 11-point Likert scale)

Secondary outcome:

Neuropathic Pain Sympton Inventory (NPSI)

Activity as captured by the Actiwatch Score device

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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.

Locations and Contacts

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Linkoping 581 85, Sweden; Recruiting

Pfizer Investigational Site, Jonkoping 551 85, Sweden; Recruiting

Pfizer Investigational Site, Calgary, Alberta T2N 4N1, Canada; Not yet recruiting

Pfizer Investigational Site, Sarnia, Ontario N7T 4X3, Canada; Recruiting

Pfizer Investigational Site, Hamilton, Ontario L8N 3Z5, Canada; Not yet recruiting

Additional Information

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

Starting date: May 2008
Ending date: March 2009
Last updated: October 13, 2008

Page last updated: November 03, 2008

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