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

NCT01119222 | Completed Phase 1 Results

• 1 other identifier: A9001388
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Cold pain methodology; Healthy male volunteers; gabapentin; Diphenhydramine; morphine

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (6)

• Number of Participants With Clinically Significant Findings in Vital Signs

  Predose, Day 1, Day 2 each treatment period, follow-up visit (at least 7 days after last dosing)

• Number of Participants With Clinically Significant Abnormal Findings on Physical Examination

  Pre-dose and follow-up visit (at least 7 days after last dosing)

• Number of Participants With Abnormal Findings on Electrocardiogram (ECG)

  Pre-dose and follow-up visit (at least 7 days after last dosing)

• Number of Participants With Abnormal Haematology, Clinical Chemistry, Urinalysis Results

  Pre-dose, follow-up visit (at least 7 days after last dosing)

• Number of Participants With Abnormal Cardiac Monitoring Results

  Pre-dose through duration of IV infusion dosing

Study Arms (4)

Gabapentin 1200mg

ACTIVE COMPARATOR

Drug: Gabapentin

Diphenhydramine 50 mg

ACTIVE COMPARATOR

Drug: Diphenhydramine

Morphine 10 mg

ACTIVE COMPARATOR

Drug: Morphine

Placebo formulations

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Gabapentin DRUG

Capsule, single 1200mg dose

Gabapentin 1200mg

Diphenhydramine DRUG

Tablet, single 50mg dose

Diphenhydramine 50 mg

Morphine DRUG

IV, single 10mg dose

Morphine 10 mg

Placebo DRUG

Placebo formulations (Capsule, tablet, IV to match the active treatments and to be administered in a double-dummy fashion).

Placebo formulations

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Brussels, 1070, Belgium

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Gabapentin; Diphenhydramine; Morphine

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Ethylamines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 5, 2010
• First Posted: May 7, 2010
• Study Start: July 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: March 7, 2011
• Results First Posted: March 7, 2011

Record last verified: 2011-02

Locations

BE (1)