Study To Assess The Effect Of Gabapentin, Diphenhydramine And Morphine On Cold Pain In Healthy Male Volunteers

Condition(s) targeted: Healthy

Intervention: Gabapentin (Drug); Diphenhydramine (Drug); Morphine (Drug); Placebo (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Pfizer

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

Human experimental pain models are useful in understanding the mechanisms underlying clinical pain conditions and can be used to test the analgesic efficacy of drugs used in the management of pain. Once established these models can be used as mechanism biomarkers in early development clinical studies to establish proof of mechanism for novel compounds. The cold pain model is a mechanistic pain biomarker with potential application in proof of mechanism studies. In this study we aim to set up this cold pain model at a Clinical Research Unit and demonstrate we can effectively screen subjects for this model and examine the effect of morphine, diphenhydramine, and gabapentin in the cold pain model.

Official title: A Randomised, Double-Blind, Double-Dummy, Placebo And Active Controlled, 4-Way Crossover Methodology Study To Assess The Effect Of Gabapentin, Diphenhydramine And Morphine On Cold Pain In Healthy Male Volunteers

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Primary outcome:

Average Pain (0-120 Seconds): Cold Pain Test Visual Analog Scale (VAS)

Interpolated Average Pain (0-8 Hours)

Secondary outcome:

Number of Participants With Clinically Significant Findings in Vital Signs

Number of Participants With Clinically Significant Abnormal Findings on Physical Examination

Number of Participants With Abnormal Findings on Electrocardiogram (ECG)

Number of Participants With Abnormal Haematology, Clinical Chemistry, Urinalysis Results

Number of Participants With Abnormal Cardiac Monitoring Results

Number of Participants With Abnormal Pulse Oxymetry Results

Detailed description: Cold pain methodology development

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Healthy male volunteers having given consent to participate in the study who have no

clinically significant anomalies and whose vital signs are within normal range.

- Subject having performed the cold pain test reproducibly ie, if the area under the

pain-time curve (AUC) must be within 20% during successive tests within one cold pain test screening visit and within 30% between the two cold pain test screening visits. Exclusion Criteria:

- Subject who have had a serious adverse reaction or significant hypersensitivity to

any of the study drugs.

- Subjects with a history of or evidence of any neurological condition which could

affect pain sensation.

- Subjects with an AUCcpt 0-120 sec in the cold pain test of <1000 in any of the

screening tests (excluding familiarization).

Pfizer Investigational Site, Bruxelles 1070, Belgium

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

Starting date: July 2008
Last updated: February 10, 2011