Study to Evaluate the Safety of Post-Operative TZP-101 (IV Ulimorelin) After Partial Bowel Resection (NCT01710982) | Clinical Trial Compass
CompletedPhase 3
Study to Evaluate the Safety of Post-Operative TZP-101 (IV Ulimorelin) After Partial Bowel Resection
27 participantsStarted 2012-02
Plain-language summary
A study to evaluate the safety of TZP-101 in comparison with placebo when administered post-operatively in patients who have undergone partial bowel resection.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient is 18 to 80 years of age, inclusive.
* Patient is scheduled to undergo open bowel resection.
* Female patients must be postmenopausal (for at least 1 year), surgically sterile, practicing true sexual abstinence, OR must be using adequate contraception (in the opinion of the investigator) for the duration of the study, including the follow-up period (e.g. contraceptive implants, injectables, oral contraceptives, some intrauterine devices \[IUD\], and/or barrier method (condom or occlusive cap) with spermicidal foam/gel/film/cream/suppository).
* Hormonal and IUD methods of contraception must be established for a period of 3 months prior to dosing and, if changed, alternative methods should be used as directed by the investigator throughout the duration of the study.
* Females of childbearing potential must have a negative pregnancy test at screening and admission
After surgery and prior to administration of the first dose of study drug, the following eligibility criteria must be assessed:
* Patient underwent open bowel resection.
* Patient has given written informed consent
Exclusion Criteria:
* Patient weighs more than 200kg (441 pounds).
* Patient is classified as American Society of Anesthesiologists (ASA) Class 4, 5, or 6
* Patient has complete bowel obstruction.
* Patient is scheduled to receive a low rectal or anal anastomosis (e.g. proctectomy or ileoanal anastomosis) (low rectal is defined as below the anterior peritoneal reflection -…
What they're measuring
1
Number of Participants with Treatment Emergent Adverse Events as a Measure of Safety and Tolerability