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NCT Number: NCT01119222

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

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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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Brussels, 1070, Belgium

About this study

Cold pain methodology development

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Gabapentin

Drug

Capsule, single 1200mg dose

diphenhydramine

Drug

Tablet, single 50mg dose

Morphine

Drug

IV, single 10mg dose

Placebo

Drug

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

Primary outcomes

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

    Time frame: Pre-dose, 1, 1.5, 2, 4, and 8 hours post-dose

    Area under the cold pain test Visual Analog Scale (VAS) time curve (AUCcpt 0 to 120 seconds [sec]) averaged over the 120 sec for each time point assessed. Participant adjusted 100 millimeter (mm) electronic VAS with range of "no pain" (0) to "maximum pain" (100) at the anchor endpoints of the scale and "moderate pain" at the midpoint. Pain reported while non-dominant hand was placed in thermostatically controlled water bath at 2±1°C for a maximum of 120 sec.

  2. Interpolated Average Pain (0-8 Hours)

    Time frame: Pre-dose to 8 hours post-dose

    Interpolated average pain (0 to 8 hours): area under the curve (AUC) of average pain (0 to 120 seconds) recorded at each of the time points taken over 8 hour time period divided by 8.

Secondary outcomes

  1. Number of Participants With Clinically Significant Findings in Vital Signs

    Time frame: Predose, Day 1, Day 2 each treatment period, follow-up visit (at least 7 days after last dosing)

    Supine blood pressure measured to nearest millimeter of mercury (mmHg), pulse rate measured with automated device or manually in the brachial/radial artery for at least 30 seconds.

  2. Number of Participants With Clinically Significant Abnormal Findings on Physical Examination

    Time frame: Pre-dose and follow-up visit (at least 7 days after last dosing)

    Full physical examination consisting of an examination of the abdomen, cardiovascular systems, lungs, lymph nodes, mouth, musculoskeletal and neurological systems, skin, extremities, head, ears, eyes, nose, throat and thyroid gland.

  3. Number of Participants With Abnormal Findings on Electrocardiogram (ECG)

    Time frame: Pre-dose and follow-up visit (at least 7 days after last dosing)

    Standard 12-lead ECG performed after subject had rested quietly for at least 10 minutes in a supine position.

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

    Time frame: Pre-dose, follow-up visit (at least 7 days after last dosing)

    Standard haematology, clinical chemistry, and urinalysis safety laboratory tests.

  5. Number of Participants With Abnormal Cardiac Monitoring Results

    Time frame: Pre-dose through duration of IV infusion dosing

    Continuous cardiac monitoring during intervenous (IV) infusion dosing (morphine or placebo).

  6. Number of Participants With Abnormal Pulse Oxymetry Results

    Time frame: Predose through duration of IV infusion dosing

    Pulse oxymetry to monitor percentage of hemoglobin saturated with oxygen during intervenous (IV) infusion dosing (morphine or placebo).

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
May 7, 2010
Registry last updated
Mar 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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