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Morphine-Sparing Efficacy Of Parecoxib In Pain Treatment After Radical Prostatectomy (PROSTATECTOMY)

21 septembre 2011 mis à jour par: 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.

Aperçu de l'étude

Statut

Résilié

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

105

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Allemagne
      • Essen, Allemagne, 45136
        • Pfizer Investigational Site
      • Heidelberg, Allemagne, 69121
        • Pfizer Investigational Site
      • Koeln, Allemagne, 50924
        • Pfizer Investigational Site
      • Reutlingen, Allemagne, 72764
        • Pfizer Investigational Site

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Homme

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Morphine plus Parecoxib
Médicament: Morphine, Parecoxib
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.
Comparateur actif: Morphine and Placebo
Médicament: Morphine, Placebo
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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Cumulative Amount of Morphine Administered in the First 24 Hours Following Surgery
Délai: 24 hours post surgery
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.
24 hours post surgery

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Cumulative Amount of Morphine Administered in the First 48 Hours Following Surgery
Délai: 48 hours post surgery
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.
48 hours post surgery
Time to Last Administration of Morphine
Délai: baseline (end of surgery) to 48 hours post surgery
Time from last surgical stitch after prostatectomy to last administration of morphine (PCA and/or bolus).
baseline (end of surgery) to 48 hours post surgery
Amount of Blood Loss
Délai: 48 hours post surgery
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.
48 hours post surgery
Number of Participants With Blood Loss Requiring Red Blood Cell (RBC) Transfused Units
Délai: 48 hours post surgery
48 hours post surgery
Pain Intensity Score
Délai: 12, 24, 36, and 48 hours post surgery

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
Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Severity Composite Score
Délai: 24 and 48 hours post surgery
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).
24 and 48 hours post surgery
Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference Composite Score
Délai: 24 and 48 hours post surgery
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.
24 and 48 hours post surgery
Opiate Related Symptom Distress Scale (OR-SDS) Questionnaire: Overall Composite Score
Délai: 24 and 48 hours post surgery
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.
24 and 48 hours post surgery

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Number of Participants With Rating of Global Evaluation of Study Medication
Délai: 48 hours post surgery
Participants asked, "How would you rate the study medication you received for pain since your surgery?" choices included: Poor, Fair, Good, and Excellent.
48 hours post surgery
Number of Participants With Health Care Resource Utilization (HCRU)
Délai: 24 and 48 hours post surgery
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".
24 and 48 hours post surgery
Overall Analgesic Benefit Score (OABS)
Délai: 24 and 48 hours post surgery
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.
24 and 48 hours post surgery
Hemoglobin Concentration
Délai: 24 hours post surgery
24 hours post surgery
Total Amount of Postoperative Drainage Fluid
Délai: 24 hours post surgery
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.
24 hours post surgery

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Pfizer

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 décembre 2006

Achèvement primaire (Réel)

1 septembre 2010

Achèvement de l'étude (Réel)

1 septembre 2010

Dates d'inscription aux études

Première soumission

28 juin 2006

Première soumission répondant aux critères de contrôle qualité

28 juin 2006

Première publication (Estimation)

29 juin 2006

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

28 octobre 2011

Dernière mise à jour soumise répondant aux critères de contrôle qualité

21 septembre 2011

Dernière vérification

1 septembre 2011

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • A3481066

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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