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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01119222
• Other study ID #: A9001388
• Status: Completed
• Phase: Phase 1
• First received: May 5, 2010
• Last updated: February 10, 2011
• Start date: July 2008
• Est. completion date: October 2008

Study information

• Verified date: February 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Independent Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

Cold pain methodology development

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Gabapentin
Capsule, single 1200mg dose
• Diphenhydramine
Tablet, single 50mg dose
• Morphine
IV, single 10mg dose
• Placebo
Placebo formulations (Capsule, tablet, IV to match the active treatments and to be administered in a double-dummy fashion).

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Pain (0-120 Seconds): Cold Pain Test Visual Analog Scale (VAS)	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.	Pre-dose, 1, 1.5, 2, 4, and 8 hours post-dose	No
Primary	Interpolated Average Pain (0-8 Hours)	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.	Pre-dose to 8 hours post-dose	No
Secondary	Number of Participants With Clinically Significant Findings in Vital Signs	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.	Predose, Day 1, Day 2 each treatment period, follow-up visit (at least 7 days after last dosing)	Yes
Secondary	Number of Participants With Clinically Significant Abnormal Findings on Physical Examination	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.	Pre-dose and follow-up visit (at least 7 days after last dosing)	Yes
Secondary	Number of Participants With Abnormal Findings on Electrocardiogram (ECG)	Standard 12-lead ECG performed after subject had rested quietly for at least 10 minutes in a supine position.	Pre-dose and follow-up visit (at least 7 days after last dosing)	Yes
Secondary	Number of Participants With Abnormal Haematology, Clinical Chemistry, Urinalysis Results	Standard haematology, clinical chemistry, and urinalysis safety laboratory tests.	Pre-dose, follow-up visit (at least 7 days after last dosing)	Yes
Secondary	Number of Participants With Abnormal Cardiac Monitoring Results	Continuous cardiac monitoring during intervenous (IV) infusion dosing (morphine or placebo).	Pre-dose through duration of IV infusion dosing	Yes
Secondary	Number of Participants With Abnormal Pulse Oxymetry Results	Pulse oxymetry to monitor percentage of hemoglobin saturated with oxygen during intervenous (IV) infusion dosing (morphine or placebo).	Predose through duration of IV infusion dosing	Yes

External Links

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