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

10. februar 2011 opdateret af: Pfizer

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Cold pain methodology development

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

19

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Belgien
      • Bruxelles, Belgien, 1070
        • Pfizer Investigational Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 55 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Han

Beskrivelse

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).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Gabapentin 1200mg
Medicin: Gabapentin
Capsule, single 1200mg dose
Aktiv komparator: Diphenhydramine 50 mg
Medicin: Diphenhydramine
Tablet, single 50mg dose
Aktiv komparator: Morphine 10 mg
Medicin: Morphine
IV, single 10mg dose
Placebo komparator: Placebo formulations
Medicin: Placebo
Placebo formulations (Capsule, tablet, IV to match the active treatments and to be administered in a double-dummy fashion).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Average Pain (0-120 Seconds): Cold Pain Test Visual Analog Scale (VAS)
Tidsramme: 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.
Pre-dose, 1, 1.5, 2, 4, and 8 hours post-dose
Interpolated Average Pain (0-8 Hours)
Tidsramme: 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.
Pre-dose to 8 hours post-dose

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Clinically Significant Findings in Vital Signs
Tidsramme: 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.
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
Tidsramme: 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.
Pre-dose and follow-up visit (at least 7 days after last dosing)
Number of Participants With Abnormal Findings on Electrocardiogram (ECG)
Tidsramme: 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.
Pre-dose and follow-up visit (at least 7 days after last dosing)
Number of Participants With Abnormal Haematology, Clinical Chemistry, Urinalysis Results
Tidsramme: Pre-dose, follow-up visit (at least 7 days after last dosing)
Standard haematology, clinical chemistry, and urinalysis safety laboratory tests.
Pre-dose, follow-up visit (at least 7 days after last dosing)
Number of Participants With Abnormal Cardiac Monitoring Results
Tidsramme: Pre-dose through duration of IV infusion dosing
Continuous cardiac monitoring during intervenous (IV) infusion dosing (morphine or placebo).
Pre-dose through duration of IV infusion dosing
Number of Participants With Abnormal Pulse Oxymetry Results
Tidsramme: 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).
Predose through duration of IV infusion dosing

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pfizer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2008

Primær færdiggørelse (Faktiske)

1. oktober 2008

Studieafslutning (Faktiske)

1. oktober 2008

Datoer for studieregistrering

Først indsendt

5. maj 2010

Først indsendt, der opfyldte QC-kriterier

6. maj 2010

Først opslået (Skøn)

7. maj 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

7. marts 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. februar 2011

Sidst verificeret

1. februar 2011

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • A9001388

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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