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

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

Overview[ - collapse ][ - ]

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	Healthy
Intervention	Drug: Gabapentin Drug: Diphenhydramine Drug: Morphine Drug: Placebo
Phase	Phase 1
Sponsor	Pfizer
Responsible Party	Pfizer
ClinicalTrials.gov Identifier	NCT01119222
First Received	May 5, 2010
Last Updated	February 10, 2011
Last verified	February 2011

Tracking Information[ + expand ][ + ]

First Received Date	May 5, 2010
Last Updated Date	February 10, 2011
Start Date	July 2008
Estimated Primary Completion Date	October 2008
Current 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.
Current 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).

Descriptive Information[ + expand ][ + ]

Brief Title	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
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
Study Type	Interventional
Study Phase	Phase 1
Study Design	Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)
Condition	Healthy
Intervention	Drug: Gabapentin Capsule, single 1200mg dose Drug: Diphenhydramine Tablet, single 50mg dose Drug: Morphine IV, single 10mg dose Drug: Placebo Placebo formulations (Capsule, tablet, IV to match the active treatments and to be administered in a double-dummy fashion).
Study Arm (s)	Active Comparator: Gabapentin 1200mg Active Comparator: Diphenhydramine 50 mg Active Comparator: Morphine 10 mg Placebo Comparator: Placebo formulations

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	19
Estimated Completion Date	October 2008
Estimated Primary Completion Date	October 2008
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).
Gender	Male
Ages	18 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	Belgium

Administrative Information[ + expand ][ + ]

NCT Number	NCT01119222
Other Study ID Numbers	A9001388
Has Data Monitoring Committee	No
Information Provided By	Pfizer
Study Sponsor	Pfizer
Collaborators	Not Provided
Investigators	Study Director: Pfizer CT.gov Call Center Pfizer
Verification Date	February 2011

Locations[ + expand ][ + ]