- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
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Connecticut
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Hartford, Connecticut, Forente stater, 06102-5037
- Hartford Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Placebo komparator: 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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Aktiv komparator: Entereg
|
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)
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
length of stay in days
Tidsramme: 7-10 days s/p discharge
|
7-10 days s/p discharge
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- JOHN002914HE
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Kliniske studier på Laparoscopic Colonic Resection
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Copenhagen Academy for Medical Education and SimulationFullført
-
Seoul National University HospitalRekrutteringLARS - Low Anterior Resection SyndromeKorea, Republikken
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Ankara UniversityAarhus University Hospital; Dokuz Eylul University; Lokman Hekim ÜniversitesiFullførtLARS - Low Anterior Resection Syndrome
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University of Roma La SapienzaFullførtColonic DiverticulaBrasil, Italia, Litauen, Polen, Romania, Storbritannia, Venezuela
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Maastricht University Medical CenterUkjent
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King's College Hospital NHS TrustFullført
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HEM Pharma Inc.Premier Research Group plcHar ikke rekruttert ennåLARS - Low Anterior Resection Syndrome
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Cook Group IncorporatedFullførtKolonpolypp | Angiodysplasi | Colonic DiverticulaCanada
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KU LeuvenUniversitaire Ziekenhuizen KU LeuvenHar ikke rekruttert ennåEndetarmskreft | LARS - Low Anterior Resection Syndrome
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Oxford University Hospitals NHS TrustFullførtEndetarmskreft | Ulcerøs kolitt | Tykktarmskreft | KolondivertikulumStorbritannia
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