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- Klinische proef NCT00346268
Morphine-Sparing Efficacy Of Parecoxib In Pain Treatment After Radical Prostatectomy (PROSTATECTOMY)
21 september 2011 bijgewerkt door: Pfizer
Randomized, Double-Blind Study Of The Morphine-Sparing Efficacy And Safety Of Parecoxib Sodium 40 Mg IV Followed By 20 Mg IV Every 12 Hours In The Treatment Of Pain Following Radical Prostatectomy
The primary objective of this study is to demonstrate the opioid-sparing efficacy of parecoxib 40 mg intravenously given as a loading dose followed by 20 mg intravenously in the 24 hours after the end of surgery.
Studie Overzicht
Toestand
Beëindigd
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
The study was terminated due to lack of recruitment due to competing alternative operation methods on 13September 2010.
The decision to terminate the trial was not based on any safety concerns.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
105
Fase
- Fase 4
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Essen, Duitsland, 45136
- Pfizer Investigational Site
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Heidelberg, Duitsland, 69121
- Pfizer Investigational Site
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Koeln, Duitsland, 50924
- Pfizer Investigational Site
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Reutlingen, Duitsland, 72764
- Pfizer Investigational Site
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Mannelijk
Beschrijving
Inclusion Criteria:
- The patient's ASA physical status is 1 or 2 and he has a low risk (i.e.,<10%) of developing an acute coronary event within the next 10 years according to the PROCAM risk assessment calculator.
- The patient is scheduled to undergo routine radical prostatectomy performed under a standardized regimen of general anesthesia, and is expected to experience moderate to severe postsurgical pain in the absence of postoperative analgesia.
Exclusion Criteria:
- The patient has a history of uncontrolled chronic disease or a concurrent clinically significant illness or medical condition such as a diagnosed chronic pain condition, which, in the Investigator's opinion, would contraindicate study participation or confound interpretation of the results
- The patient has a history or current presence of congestive heart failure (NYHA II-IV), established ischaemic heart disease, peripheral arterial disease and / or cerebrovascular disease.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: Morphine plus Parecoxib
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Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses.
Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
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Actieve vergelijker: Morphine and Placebo
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Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses.
Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Cumulative Amount of Morphine Administered in the First 24 Hours Following Surgery
Tijdsspanne: 24 hours post surgery
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Total cumulative amount of morphine administered (PCA and/or bolus) in the first 24 hours after the application of the last surgical stitch after prostatectomy.
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24 hours post surgery
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Cumulative Amount of Morphine Administered in the First 48 Hours Following Surgery
Tijdsspanne: 48 hours post surgery
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Total cumulative amount of morphine administered (PCA and/or bolus) in the first 48 hours after the application of the last surgical stitch after prostatectomy.
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48 hours post surgery
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Time to Last Administration of Morphine
Tijdsspanne: baseline (end of surgery) to 48 hours post surgery
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Time from last surgical stitch after prostatectomy to last administration of morphine (PCA and/or bolus).
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baseline (end of surgery) to 48 hours post surgery
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Amount of Blood Loss
Tijdsspanne: 48 hours post surgery
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Calculated as: ([Hb g/dL]pra + RBCUduring48)-[Hb g/dL]at 48, where [Hb g/dL]pra=blood hemoglobin concentration preoperatively in grams per deciliter (g/dL), [Hb g/dL]at 48=blood hemoglobin concentration 48 hours after skin closure, and RBCUduring48=number of red blood cell units (RBCU) substituted during and after prostatectomy until 48 hours after skin closure.
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48 hours post surgery
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Number of Participants With Blood Loss Requiring Red Blood Cell (RBC) Transfused Units
Tijdsspanne: 48 hours post surgery
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48 hours post surgery
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Pain Intensity Score
Tijdsspanne: 12, 24, 36, and 48 hours post surgery
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Pain intensity assessed immediately prior and 30 minutes after administration (admin) of study medication, participants categorized their pain intensity at rest and at movement on 0-4 numeric rating scale (NRS):0 (minimum intensity) to 4 (maximum intensity). Movement defined as sitting up from a lying into a sitting position in bed. |
12, 24, 36, and 48 hours post surgery
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Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Severity Composite Score
Tijdsspanne: 24 and 48 hours post surgery
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mBPI-sf: participant-rated 11-point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine).
Pain severity index=the mean of item scores 2 to 5 (pain at its worst in past 24 hours, pain at its least in past 24 hours, average pain level, and pain right now).
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24 and 48 hours post surgery
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Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference Composite Score
Tijdsspanne: 24 and 48 hours post surgery
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mBPI-sf: participant-rated 11-point Likert rating scale ranging from 0 (does not interfere) to 10 (completely interferes) with functional activities (general activity, mood, walking ability, relations with other people, sleep, coughing, deep breathing, and concentration) in past 24 hours.
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24 and 48 hours post surgery
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Opiate Related Symptom Distress Scale (OR-SDS) Questionnaire: Overall Composite Score
Tijdsspanne: 24 and 48 hours post surgery
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Participant-rated scale assessed 10 common opiate related symptoms by 3 ordinal measures: frequency (1 to 4 scale: rarely to almost constantly), severity (1 to 4 scale: slight to very severe) and bothersomeness (1 to 5 scale: not at all to very much).
Frequency and severity items assigned numeric scores 1 to 4. Bothersomeness items scaled in order to assign numeric scores 0.8 to 4.0 (not at all scored=0.8,
a little bit=1.6,
somewhat=2.4,
quite a bit=3.2,
and very much=4.0).
Overall composite score=mean of each 10 individual mean symptoms' OR-SDS scores; ranged from 1 to 4.
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24 and 48 hours post surgery
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Number of Participants With Rating of Global Evaluation of Study Medication
Tijdsspanne: 48 hours post surgery
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Participants asked, "How would you rate the study medication you received for pain since your surgery?" choices included: Poor, Fair, Good, and Excellent.
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48 hours post surgery
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Number of Participants With Health Care Resource Utilization (HCRU)
Tijdsspanne: 24 and 48 hours post surgery
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Supervising physician or nurse answered question in the presence of participant, "In the last 24 hours, did the participant receive any unscheduled consultation from any of the following specialist: anesthesiologist, surgeon, nurse or other specialist".
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24 and 48 hours post surgery
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Overall Analgesic Benefit Score (OABS)
Tijdsspanne: 24 and 48 hours post surgery
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Participants' rating of global assessment of analgesic experience.
OABS comprised of scores for symptoms (vomiting, itching, sweating, freezing, and dizziness) and patient satisfaction; Participants asked how much did symptoms distress and bother them during the last 24 hours; Participants asked how satisfied they have been with treatment of pain during last 24 hours.
Each symptom and satisfaction question scored from 0 (not at all) to 4 (very much so).
Total possible score=0 to 24.
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24 and 48 hours post surgery
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Hemoglobin Concentration
Tijdsspanne: 24 hours post surgery
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24 hours post surgery
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Total Amount of Postoperative Drainage Fluid
Tijdsspanne: 24 hours post surgery
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After removal of the prostate and placement of the urine catheter, at least one easy-flow drainage was placed in the perivesical space.
Drainage fluid (a mixture with a variable combination of blood and urine) was measured.
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24 hours post surgery
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 december 2006
Primaire voltooiing (Werkelijk)
1 september 2010
Studie voltooiing (Werkelijk)
1 september 2010
Studieregistratiedata
Eerst ingediend
28 juni 2006
Eerst ingediend dat voldeed aan de QC-criteria
28 juni 2006
Eerst geplaatst (Schatting)
29 juni 2006
Updates van studierecords
Laatste update geplaatst (Schatting)
28 oktober 2011
Laatste update ingediend die voldeed aan QC-criteria
21 september 2011
Laatst geverifieerd
1 september 2011
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Pathologische processen
- Postoperatieve complicaties
- Pijn
- Neurologische manifestaties
- Pijn, postoperatief
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Depressiva van het centrale zenuwstelsel
- Agenten van het perifere zenuwstelsel
- Enzymremmers
- Pijnstillers
- Sensorische systeemagenten
- Ontstekingsremmers, niet-steroïde
- Pijnstillers, niet-narcotisch
- Ontstekingsremmende middelen
- Antireumatische middelen
- Cyclo-oxygenaseremmers
- Pijnstillers, opioïden
- Verdovende middelen
- Cyclo-oxygenase 2-remmers
- Morfine
- Parecoxib
Andere studie-ID-nummers
- A3481066
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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