Comparison of the Efficacy and Safety of Q8003 Versus Its Individual Components in Bunionectomy Patients
15. maj 2012 opdateret af: QRxPharma Inc.
A Double-Blind, Randomized, Multi-Center, Repeat-Dose, Comparison of the Analgesic Efficacy and Safety of the Opioid Combination Q8003 to Each of the Individual Milligram Components (Oxycodone and Morphine) in the Management of Acute Moderate to Severe Pain Following Bunionectomy Surgery
This is a randomized, double-blind, multicenter, fixed dose factorial study of Q8003 12 mg/8 mg and Q8003 6 mg/4 mg versus its individual morphine sulfate and oxycodone hydrochloride components for the management of acute moderate to severe postoperative pain following bunionectomy surgery.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
197
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Arizona
-
Phoenix, Arizona, Forenede Stater, 85050
- Associated Foot and Ankle Specialists
-
-
California
-
Anaheim, California, Forenede Stater, 92801
- Advanced Clinical Research Institute
-
-
Maryland
-
Owings Mills, Maryland, Forenede Stater, 21117
- Crossroads Research, Inc.
-
Pasadena, Maryland, Forenede Stater, 21122
- Chesapeake Foot and Ankle
-
-
Pennsylvania
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Altoona, Pennsylvania, Forenede Stater, 92801
- Advanced Regional Center for Ankle and Foot Care
-
-
Utah
-
Salt Lake City, Utah, Forenede Stater, 84124
- Jean Brown Research
-
-
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 og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Patient is male or female and at least 18 years of age.
- Females must be non-pregnant, non-lactating, and practicing an acceptable method of birth control, or be surgically sterile or postmenopausal (amenorrhea for ≥ 12 months). Non-pregnancy will be confirmed by pregnancy tests conducted at Screening and Pre-treatment.
- Patient is scheduled for bunionectomy surgery, meets the criteria of an ASA Class I to III, and is willing to stay in the study center for at least 48 hours from the initial dose of study medication post surgery.
- To be randomized after surgery, the patient must report moderate to severe pain (a score of 2 or more on the 4 point Likert scale or at least 4 on the 11 point NPRS scale).
Exclusion Criteria:
- In the opinion of the Investigator, has a history of pulmonary, cardiovascular (including uncontrolled hypertension), neurologic, endocrine, hepatic, gastrointestinal, or kidney disease or therapy that, in the opinion of the Investigator, would jeopardize the patient's well being by participation in this study or is mentally or emotionally unsuitable to participate, or unable/unwilling to comply with the study assessments.
- Used opiates continuously (including tramadol) for more than ten days in the past year.
- Hypersensitivity or poor tolerance to ibuprofen or short term opioids.
- Currently receiving any medications that are not at a stable dose (the same dose for > 2 months prior to date of surgery).
- Was dosed with another investigational drug within 30 days prior to the Screening Visit or has previously received treatment with Q8003.
- Current therapy with central nervous system depressant medications that might increase the risks of treatment with opioids (other than those used with surgical anesthesia).
- Current evidence of alcohol abuse (regularly drinks more than 4 units of alcohol per day; 1 unit = ½ pint of beer, 1 glass of wine, or 1 ounce of spirit).
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Morphine sulfate 12 mg
Single component
|
One morphine sulfate 12mg IR capsule q6h
Two morphine sulfate 3mg IR capsules q6h
|
|
Eksperimentel: Q8003 12mg/8mg
Combination
|
One Q8003 (morphine sulfate and oxycodone HCl) 12mg/8mg IR Capsule q6h
One Q8003 (morphine sulfate and oxycodone HCl) 6mg/4mg IR Capsule q6h
|
|
Aktiv komparator: Oxycodone HCl 8mg
Single component
|
One oxycodone HCl 8mg IR Capsule q6h
|
|
Eksperimentel: Q8003 6mg/4mg
Combination
|
One Q8003 (morphine sulfate and oxycodone HCl) 12mg/8mg IR Capsule q6h
One Q8003 (morphine sulfate and oxycodone HCl) 6mg/4mg IR Capsule q6h
|
|
Aktiv komparator: Morphine sulfate 6mg
Single component
|
One morphine sulfate 12mg IR capsule q6h
Two morphine sulfate 3mg IR capsules q6h
|
|
Aktiv komparator: Oxycodone HCl 4mg
Single component
|
Two oxycodone HCl 2mg IR Capsules q6h
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Forskel i smerteintensitetsscore fra baseline
Tidsramme: 48 timer
|
48 timer
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Safety: adverse events
Tidsramme: 48 hours
|
48 hours
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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. december 2008
Primær færdiggørelse (Faktiske)
1. januar 2009
Studieafslutning (Faktiske)
1. februar 2009
Datoer for studieregistrering
Først indsendt
27. januar 2009
Først indsendt, der opfyldte QC-kriterier
27. januar 2009
Først opslået (Skøn)
28. januar 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
17. maj 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. maj 2012
Sidst verificeret
1. maj 2012
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Postoperative komplikationer
- Smerte
- Neurologiske manifestationer
- Smerter, postoperativ
- Lægemidlers fysiologiske virkninger
- Depressive midler til centralnervesystemet
- Agenter fra det perifere nervesystem
- Analgetika
- Sensoriske systemagenter
- Analgetika, Opioid
- Narkotika
- Morfin
- Oxycodon
Andre undersøgelses-id-numre
- Q8003-021
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 .