Clinical trial NCT01119222: Study To Assess The Effect Of Gabapentin, Diphenhydramine And Morphine On Cold Pain In Healthy Male Volunteers
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Cold pain methodology
Healthy male volunteers
gabapentin
Diphenhydramine
morphine
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-05-07
Enrollment: 19
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: 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.

Detailed description: Cold pain methodology development

Eligibility 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).

Primary outcomes:
measure: Average Pain (0-120 Seconds): Cold Pain Test Visual Analog Scale (VAS)
timeFrame: Pre-dose, 1, 1.5, 2, 4, and 8 hours post-dose
measure: Interpolated Average Pain (0-8 Hours)
timeFrame: Pre-dose to 8 hours post-dose
Secondary outcomes:
measure: Number of Participants With Clinically Significant Findings in Vital Signs
timeFrame: Predose, Day 1, Day 2 each treatment period, follow-up visit (at least 7 days after last dosing)
measure: Number of Participants With Clinically Significant Abnormal Findings on Physical Examination
timeFrame: Pre-dose and follow-up visit (at least 7 days after last dosing)
measure: Number of Participants With Abnormal Findings on Electrocardiogram (ECG)
timeFrame: Pre-dose and follow-up visit (at least 7 days after last dosing)
measure: Number of Participants With Abnormal Haematology, Clinical Chemistry, Urinalysis Results
timeFrame: Pre-dose, follow-up visit (at least 7 days after last dosing)
measure: Number of Participants With Abnormal Cardiac Monitoring Results
timeFrame: Pre-dose through duration of IV infusion dosing
measure: Number of Participants With Abnormal Pulse Oxymetry Results
timeFrame: Predose through duration of IV infusion dosing
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: