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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Bruxelles, , 1070 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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 screening tests (excluding familiarization).

NCT01119222
Pfizer
Completed
Study To Assess The Effect Of Gabapentin, Diphenhydramine And Morphine On Cold Pain In Healthy Male Volunteers

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Study To Assess The Effect Of Gabapentin, Diphenhydramine And Morphine On Cold Pain In Healthy Male Volunteers
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
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.
Cold pain methodology development
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Healthy
  • 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).
  • Active Comparator: Gabapentin 1200mg
    Intervention: Drug: Gabapentin
  • Active Comparator: Diphenhydramine 50 mg
    Intervention: Drug: Diphenhydramine
  • Active Comparator: Morphine 10 mg
    Intervention: Drug: Morphine
  • Placebo Comparator: Placebo formulations
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
October 2008
October 2008   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: Male
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT01119222
A9001388
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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1-800-718-1021

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