Safety and Efficacy of Ipamorelin for Management of Post-Operative Ileus
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ClinicalTrials.gov Identifier: NCT00672074 |
Recruitment Status :
Completed
First Posted : May 6, 2008
Last Update Posted : April 14, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ileus | Drug: Ipamorelin Drug: placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 117 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase II, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety and Efficacy of Ipamorelin Compared to Placebo for the Management of Post-Operative Ileus in Patients |
Study Start Date : | April 2008 |
Actual Primary Completion Date : | December 2009 |
Actual Study Completion Date : | December 2009 |
Arm | Intervention/treatment |
---|---|
Active Comparator: 1 Ipamorelin |
Drug: Ipamorelin
IV
Other Name: ST |
Placebo Comparator: 2 Placebo |
Drug: placebo
IV
Other Name: ST |
- Recovery of GI function [ Time Frame: Until hospital discharge ]

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- willing to comply with protocol
- undergoing bowel resection surgery
- ASA Class I-III
- Females must not be pregnant
- Body weight 40-150 kg
Exclusion Criteria:
- mentally incompetent or unable to provide informed consent
- clinically unstable
- significant liver disease
- clinically significant lab or EKG abnormalities
- alcohol or illicit drug abuse
- history of or current surgery that would prevent proper evaluation of safety or efficacy of drug

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00672074

Study Director: | Suzan Allen | Helsinn Therapeutics (U.S.), Inc |
Responsible Party: | Helsinn Therapeutics (U.S.), Inc |
ClinicalTrials.gov Identifier: | NCT00672074 |
Other Study ID Numbers: |
ST-IPAM-201 |
First Posted: | May 6, 2008 Key Record Dates |
Last Update Posted: | April 14, 2017 |
Last Verified: | April 2017 |
Postoperative Ileus |
Ileus Intestinal Obstruction Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |