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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2008-10-31

Brief Summary

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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.

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Detailed Description

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Cold pain methodology development

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Gabapentin 1200mg

Group Type ACTIVE_COMPARATOR

Gabapentin

Intervention Type DRUG

Capsule, single 1200mg dose

Diphenhydramine 50 mg

Group Type ACTIVE_COMPARATOR

Diphenhydramine

Intervention Type DRUG

Tablet, single 50mg dose

Morphine 10 mg

Group Type ACTIVE_COMPARATOR

Morphine

Intervention Type DRUG

IV, single 10mg dose

Placebo formulations

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo formulations (Capsule, tablet, IV to match the active treatments and to be administered in a double-dummy fashion).

Interventions

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Gabapentin

Capsule, single 1200mg dose

Intervention Type DRUG

Diphenhydramine

Tablet, single 50mg dose

Intervention Type DRUG

Morphine

IV, single 10mg dose

Intervention Type DRUG

Placebo

Placebo formulations (Capsule, tablet, IV to match the active treatments and to be administered in a double-dummy fashion).

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes