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.
|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|
- 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.
- 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).
|Study Start Date:||July 2008|
|Study Completion Date:||October 2008|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
|Active Comparator: Gabapentin 1200mg||
Capsule, single 1200mg dose
|Active Comparator: Diphenhydramine 50 mg||
Tablet, single 50mg dose
|Active Comparator: Morphine 10 mg||
IV, single 10mg dose
|Placebo Comparator: Placebo formulations||
Placebo formulations (Capsule, tablet, IV to match the active treatments and to be administered in a double-dummy fashion).
Cold pain methodology development
Please refer to this study by its ClinicalTrials.gov identifier: NCT01119222
|Pfizer Investigational Site|
|Bruxelles, Belgium, 1070|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|