- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01258569
Entereg Laparoscopic Colon Resection Study
Entereg (Alvimopan) is a peripherally acting mu-opioid receptor antagonist that has been shown to increase postoperative bowel function in patients after open bowel resection surgery. It has been proven safe and effective for short-term in-house treatment. At the present there are several Drug Use Utilization Evaluation studies reporting results involving the use of alvimopan (ENTEREG) in laparoscopic bowel resection patients. However, this study will be the first randomized, prospective, double-blind, placebo-controlled trial looking at this population. We propose that Entereg will decrease the length of stay by one day in the laparoscopic colon resection patient. We wish to perform a voluntary, double-blinded, placebo controlled study. We plan an enrollment population of 250 patients. Twelve milligrams of Entereg will be administered 30 minutes to 5 hours pre-op followed by 12 mg BID, up to 7 days or 15 total doses. The primary endpoint of the study will be length of stay. The time of GI-2 recovery (toleration of solid food and first bowel movement) and time to GI-3 recovery (toleration of solid food, and flatus or bowel movement) will be secondary endpoints.
Estimated Enrollment = 250, Study Start Date: November 2010, Estimated Study Completion Date: May 2012, Estimated Primary Completion Date: Nov 2011.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Connecticut
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Hartford, Connecticut, États-Unis, 06102-5037
- Hartford Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
Subject is scheduled to undergo laparoscopic (straight or hand assisted) elective colon resection with primary anastamosis Subject is >18 years of age Subjects can be either male or female Negative pregnancy test (if patient is a premenopausal female) Medically stable as determined by the treating surgeon- i.e., subject has an American Society of Anesthesiologists Physical Status Score of I to III.
Subject understands the study procedures, agrees to participate in the study as per the study protocol, and has voluntarily provided informed consent Patients who will be receiving IV Opioid therapy post surgery for pain management.
Exclusion Criteria:
Subject is pregnant or lactating Subject is currently using opioids or has taken more than 3 doses of opioids (oral or parenteral) in the week prior to surgery.
Subject has complete bowel obstruction Subject is not able to understand the informed consent document or is unable to give informed consent Patients who will receive a thoracic epidural for pain management post surgery. Subject has any medical instability or any condition at screening/enrollment which, in the opinion of the investigator, might confound the results of the study or pose additional risk to the subject during the administration of study procedures.
Plan d'étude
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 |
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Comparateur placebo: Placebo
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12 mg oral 30-300 min pre-op then BID up to 7 days (or 15 doses)
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Comparateur actif: Entereg
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Alvimopan (Entereg), an oral peripherally- acting mu-opioid receptor antagonist, is the first and only drug approved by the FDA to accelerate the time to upper and lower GI recovery in after partial large or small bowel resection surgery with primary anastomosis.
oral, 12 mg 30-300 min pre-op then BID up to 7 days (or 15 total doses)
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
length of stay in days
Délai: 7-10 days s/p discharge
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7-10 days s/p discharge
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- JOHN002914HE
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