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
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Gabapentin Drug: Diphenhydramine Drug: Morphine Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|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|
|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).
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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).
- 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).
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
|Pfizer Investigational Site|
|Bruxelles, Belgium, 1070|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|