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

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ClinicalTrials.gov Identifier: NCT01119222
Recruitment Status : Completed
First Posted : May 7, 2010
Results First Posted : March 7, 2011
Last Update Posted : March 7, 2011
Sponsor:
Information provided by:
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Gabapentin Drug: Diphenhydramine Drug: Morphine Drug: Placebo Phase 1

Detailed Description:
Cold pain methodology development
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
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 Start Date : July 2008
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Gabapentin 1200mg Drug: Gabapentin
Capsule, single 1200mg dose
Active Comparator: Diphenhydramine 50 mg Drug: Diphenhydramine
Tablet, single 50mg dose
Active Comparator: Morphine 10 mg Drug: Morphine
IV, single 10mg dose
Placebo Comparator: Placebo formulations Drug: Placebo
Placebo formulations (Capsule, tablet, IV to match the active treatments and to be administered in a double-dummy fashion).


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01119222


Locations
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Belgium
Pfizer Investigational Site
Bruxelles, Belgium, 1070
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01119222    
Other Study ID Numbers: A9001388
First Posted: May 7, 2010    Key Record Dates
Results First Posted: March 7, 2011
Last Update Posted: March 7, 2011
Last Verified: February 2011
Keywords provided by Pfizer:
Cold pain methodology
Healthy male volunteers
gabapentin
Diphenhydramine
morphine
Additional relevant MeSH terms:
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Diphenhydramine
Promethazine
Morphine
Gabapentin
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
 Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Anesthetics, Local
Anesthetics
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents