IleusPhase 2NCT00672074
Safety and Efficacy of Ipamorelin for Management of Post-Operative Ileus
A Phase 2 study testing Ipamorelin in people with Ileus, run by Helsinn Therapeutics (U.S.), Inc at 19 sites in United States.
Trial summary
The purpose of this study is to determine if ipamorelin is safe and effective in the management of post-operative ileus. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ileus
- What is being tested?
- Ipamorelin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 117 participants
- Where
- 19 sitesUnited States
- Study dates
- Apr 2008to Dec 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- willing to comply with protocol
- undergoing bowel resection surgery
- ASA Class I-III
- Females must not be pregnant
- Body weight 40-150 kg
Who cannot join
- 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
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
St. Joseph's Hospital of Atlanta
Atlanta, Georgia, 30342
University of Colorado Hospital
Aurora, Colorado, 80045
University of Illinois at Chicago
Chicago, Illinois, 60612
The Christ Hospital
Cincinnati, Ohio, 45219
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
Denver VA Hospital
Denver, Colorado, 80220
The Pennsylvania State University
Hershey, Pennsylvania, 17033
Indiana University Medical Center
Indianapolis, Indiana, 46202
USC/Norris Cancer Center
Los Angeles, California, 90033
Cedars Sinai Medical Center
Los Angeles, California, 90048
Ochsner Medical Center
New Orleans, Louisiana, 70121
Palo Alto Veterans Hospital
Palo Alto, California, 94304
William Beaumont Hospital
Royal Oak, Michigan, 48067
Barnes Jewish Hospital
St Louis, Missouri, 38104
Stony Brook University Medical Center
Stony Brook, New York, 11794
St. Joseph Hospital
Tacoma, Washington, 98405
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Cleveland Clinic of Weston
Weston, Florida, 33331
UMass Memorial Healthcare
Worcester, Massachusetts, 01605
About this study
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
The purpose of this study is to determine if ipamorelin is safe and effective in the management of post-operative ileus.
Read the detailed description
The safety and efficacy of ipamorelin in the management of post-operative ileus
- Conditions
- Ileus
- Being tested
- Ipamorelin, placebo
- Keywords
- Postoperative Ileus
- Medical subject headings
- Ileus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IpamorelinDrug
Also called ST
IV
placeboDrug
Also called ST
IV
| Study group | Role | What they receive |
|---|---|---|
| 1 Ipamorelin | Active comparator | Not described Receives: Drug: Ipamorelin |
| 2 Placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery of GI function
Measured: Until hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2008 (estimated)
- Study startApr 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IleusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinn Therapeutics (U.S.), Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suzan Allen, Study director, Helsinn Therapeutics (U.S.), Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00672074
- Sponsor's protocol ID
- ST-IPAM-201
- Status last verified
- Apr 2017
- First submitted
- 2 May 2008
- Last updated
- 14 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Beck DE, Sweeney WB, McCarter MD; Ipamorelin 201 Study Group. Prospective, randomized, controlled, proof-of-concept study of the Ghrelin mimetic ipamorelin for the management of postoperative ileus in bowel resection patients. Int J Colorectal Dis. 2014 Dec;29(12):1527-34. doi: 10.1007/s00384-014-2030-8. Epub 2014 Oct 21.
PubMed 25331030
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00672074
- Acronym / sponsor ID
- ST-IPAM-201
- Conditions
- Ileus
- Keywords
- Postoperative Ileus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Helsinn Therapeutics (U.S.), IncIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 6 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if ipamorelin is safe and effective in the management of post-operative ileus.
Detailed description
The safety and efficacy of ipamorelin in the management of post-operative ileus
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Ipamorelin | Active comparator | Drug: Ipamorelin |
| 2 Placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- willing to comply with protocol
- undergoing bowel resection surgery
- ASA Class I-III
- Females must not be pregnant
- Body weight 40-150 kg
Key exclusion criteria (6 listed)
- mentally incompetent or unable to provide informed consent
- clinically unstable
- significant liver disease
- clinically significant lab or EKG abnormalities
- alcohol or illicit drug abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IpamorelinAlso: STIV | Drug | 1 Ipamorelin |
| placeboAlso: STIV | Drug | 2 Placebo |
Primary outcome
Recovery of GI function
Time frame: Until hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2017.
- Derived from this study: PubMed 25331030Beck DE, Sweeney WB, McCarter MD; Ipamorelin 201 Study Group. Prospective, randomized, controlled, proof-of-concept study of the Ghrelin mimetic ipamorelin for the management of postoperative ileus in bowel resection patients. Int J Colorectal Dis. 2014 Dec;29(12):1527-34. doi: 10.1007/s00384-014-2030-8. Epub 2014 Oct 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzan Allen study director
Helsinn Therapeutics (U.S.), Inc
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ipamorelin in people with Ileus, run by Helsinn Therapeutics (U.S.), Inc at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery of GI function (time frame: Until hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00672074, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2017.