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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01119222
First received: May 5, 2010
Last updated: February 10, 2011
Last verified: February 2011
  Purpose

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 Intervention Phase
Healthy
Drug: Gabapentin
Drug: Diphenhydramine
Drug: Morphine
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • Interpolated Average Pain (0-8 Hours) [ Time Frame: Pre-dose to 8 hours post-dose ] [ Designated as safety issue: No ]
    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:
  • 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) ] [ Designated as safety issue: Yes ]
    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.

  • 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) ] [ Designated as safety issue: Yes ]
    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.

  • Number of Participants With Abnormal Findings on Electrocardiogram (ECG) [ Time Frame: Pre-dose and follow-up visit (at least 7 days after last dosing) ] [ Designated as safety issue: Yes ]
    Standard 12-lead ECG performed after subject had rested quietly for at least 10 minutes in a supine position.

  • Number of Participants With Abnormal Haematology, Clinical Chemistry, Urinalysis Results [ Time Frame: Pre-dose, follow-up visit (at least 7 days after last dosing) ] [ Designated as safety issue: Yes ]
    Standard haematology, clinical chemistry, and urinalysis safety laboratory tests.

  • Number of Participants With Abnormal Cardiac Monitoring Results [ Time Frame: Pre-dose through duration of IV infusion dosing ] [ Designated as safety issue: Yes ]
    Continuous cardiac monitoring during intervenous (IV) infusion dosing (morphine or placebo).

  • Number of Participants With Abnormal Pulse Oxymetry Results [ Time Frame: Predose through duration of IV infusion dosing ] [ Designated as safety issue: Yes ]
    Pulse oxymetry to monitor percentage of hemoglobin saturated with oxygen during intervenous (IV) infusion dosing (morphine or placebo).


Enrollment: 19
Study Start Date: July 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

Detailed Description:

Cold pain methodology development

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01119222

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

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01119222     History of Changes
Other Study ID Numbers: A9001388
Study First Received: May 5, 2010
Results First Received: October 12, 2010
Last Updated: February 10, 2011
Health Authority: Belgium: Independent Ethics Committee

Keywords provided by Pfizer:
Cold pain methodology
Healthy male volunteers
gabapentin
Diphenhydramine
morphine

Additional relevant MeSH terms:
Diphenhydramine
Promethazine
Morphine
Gabapentin
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Allergic Agents
Anesthetics, Local
Anesthetics
Sensory System Agents
Antipruritics
Dermatologic Agents
Analgesics, Opioid
Analgesics
Narcotics
Anticonvulsants
Antiparkinson Agents

ClinicalTrials.gov processed this record on July 22, 2014