Gastrointestinal DysmotilityPhase 2NCT01280344
Safety and Efficacy of Ipamorelin Compared to Placebo for the Recovery of Gastrointestinal Function
A Phase 2 study testing Saline Solution for Injection and Ipamorelin in people with Gastrointestinal Dysmotility, run by Helsinn Therapeutics (U.S.), Inc at 45 sites in United States.
Trial summary
Post-operative administration of ipamorelin is expected to reduce time to recovery of Gastrointestinal (GI) function in patients who have undergone partial small and/or large bowel resection. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Gastrointestinal Dysmotility
- What is being tested?
- Saline Solution for Injection and Ipamorelin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 45 sitesUnited States
- Study dates
- Apr 2011to May 2014
- 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
- Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form
- Males or females, 18 to 85 years of age inclusive at the time of study screening
- American Society of Anesthesiologists (ASA) Class I-III
- Have undergone a scheduled small and/or large open partial bowel resection based on a documented incision size greater than or equal to (≥) 10 cm with primary anastomosis
- Females must not be pregnant as confirmed by a serum pregnancy test at screening and by a urine pregnancy test on the day of surgery
- Body weight must be between 40-150 kilograms (kg)
Who cannot join
- Any procedure which requires a diverting stoma
- Primary anastomosis not performed at the time of surgery
- Epidural or intrathecal anesthesia
- Significant liver disease (ALT and/or total bilirubin > 2-fold upper limits of normal) or kidney disease (serum creatinine > 2.5 mg/dL) at screening
- History of irritable bowel syndrome
- Patients with a history of Crohn's disease or ulcerative colitis (UC) who have had multiple GI-related surgeries (Note: surgery naïve Crohn's or UC patients may be included)
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- History of colonic volvulus
- History of gastroesophageal surgery, gastrectomy, gastric bypass, total colectomy, short bowel syndrome, or multiple complex abdominal surgeries performed by an open procedure (uncomplicated cesarean section and appendectomy would not be considered complex)
- Patients who have received prior abdominal radiation and/or pelvic radiation
Trial locations and contacts
45 sites in 1 country.
45 sites in 1 country
United States45 sites
Study site
Atlanta, Georgia
Study site
Aurora, Colorado
Study site
Aventura, Florida
Study site
Bellevue, Washington
Study site
Burlington, Vermont
Study site
Chapel Hill, North Carolina
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Cleveland, Ohio
Study site
Columbus, Ohio
Study site
Des Moines, Iowa
Study site
Flint, Michigan
Study site
Florence, Alabama
Study site
Fountain Valley, California
Study site
Glendale, California
Study site
Hershey, Pennsylvania
Study site
Highland Park, Illinois
Study site
Houston, Texas
Study site
Indianapolis, Indiana
Study site
Inverness, Florida
Study site
Iowa City, Iowa
Study site
Jackson, Mississippi
Study site
Kansas City, Kansas
Study site
Laguna Hills, California
Study site
Los Angeles, California
Study site
Memphis, Tennessee
Study site
Miami, Florida
Study site
Milwaukee, Wisconsin
Study site
Nashville, Tennessee
Study site
Nassau Bay, Texas
Study site
New Orleans, Louisiana
Study site
Orange, California
Study site
Orlando, Florida
Study site
Pensacola, Florida
Study site
Pittsburgh, Pennsylvania
Study site
Royal Oak, Michigan
Study site
San Francisco, California
Study site
Sarasota, Florida
Study site
Sheffield, Alabama
Study site
Springfield, Massachusetts
Study site
St Louis, Missouri
Study site
Stony Brook, New York
Study site
Tampa, Florida
Study site
Troy, Michigan
Study site
Weston, Florida
About this study
Official title: Phase II Double-Blind Placebo-Controlled Dose Finding Study to Evaluate Safety/Efficacy of Ipamorelin Compared to Placebo for Recovery of Gastrointestinal Function in Patients Following Small or Large Bowel Resection w/Primary Anastomosis
Post-operative administration of ipamorelin is expected to reduce time to recovery of Gastrointestinal (GI) function in patients who have undergone partial small and/or large bowel resection.
- Conditions
- Gastrointestinal Dysmotility
- Being tested
- Saline Solution for Injection, Ipamorelin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline Solution for InjectionDrug
Intravenous (IV)
IpamorelinDrug
Intravenous (IV)
| Study group | Role | What they receive |
|---|---|---|
| 0.03 mg/kg BID | Experimental | Ipamorelin 0.03 mg/kg, BID (2 investigational drug infusions and 1 placebo infusion) Receives: Drug: Ipamorelin |
| 0.06 mg/kg BID | Experimental | Ipamorelin 0.06 mg/kg, BID (2 investigational drug infusions and 1 placebo infusion) Receives: Drug: Ipamorelin |
| 0.06 mg/kg TID | Experimental | Ipamorelin 0.06 mg/kg, TID (3 investigational drug infusions) Receives: Drug: Ipamorelin |
| Placebo | Placebo comparator | Matching placebo, TID (3 placebo infusions) Receives: Drug: Saline Solution for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery of Gastrointestinal (GI) Function
To assess the efficacy of three repeated dose levels of ipamorelin vs. placebo
Measured: Up to 10 days
Secondary outcomes (2)
Ancillary GI Functions
To investigate the effect of ipamorelin on ancillary efficacy measures of GI function and recovery
Measured: Up to 10 days or until hospital discharge
Number of Subjects with Adverse Events as a Measure of Safety and Tolerability
To investigate the safety and tolerability of ipamorelin laboratory and clinical parameters, incidence of adverse events, until hospital discharge, 14-day outpatient follow-up visit, or until resolution of adverse events
Measured: 14 day outpatient follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2011 (estimated)
- Study startApr 2011
- Primary completionJun 2013
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DysmotilityStudies 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
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinn Therapeutics (U.S.), Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01280344
- Sponsor's protocol ID
- HT-IPAM-202
- Status last verified
- Apr 2017
- First submitted
- 13 Jan 2011
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Double-Blind Placebo-Controlled Dose Finding Study to Evaluate Safety/Efficacy of Ipamorelin Compared to Placebo for Recovery of Gastrointestinal Function in Patients Following Small or Large Bowel Resection w/Primary Anastomosis
- ClinicalTrials.gov ID
- NCT01280344
- Acronym / sponsor ID
- HT-IPAM-202
- Conditions
- Gastrointestinal Dysmotility
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Helsinn Therapeutics (U.S.), IncIndustry (pharma, biotech, devices)
- Study start
- Apr 2011 (actual)
- Primary completion
- Jun 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 20 Jan 2011 (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.
Post-operative administration of ipamorelin is expected to reduce time to recovery of Gastrointestinal (GI) function in patients who have undergone partial small and/or large bowel resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0.03 mg/kg BID | Experimental | Drug: IpamorelinIpamorelin 0.03 mg/kg, BID (2 investigational drug infusions and 1 placebo infusion) |
| 0.06 mg/kg BID | Experimental | Drug: IpamorelinIpamorelin 0.06 mg/kg, BID (2 investigational drug infusions and 1 placebo infusion) |
| 0.06 mg/kg TID | Experimental | Drug: IpamorelinIpamorelin 0.06 mg/kg, TID (3 investigational drug infusions) |
| Placebo | Placebo comparator | Drug: Saline Solution for InjectionMatching placebo, TID (3 placebo infusions) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form
- Males or females, 18 to 85 years of age inclusive at the time of study screening
- American Society of Anesthesiologists (ASA) Class I-III
- Have undergone a scheduled small and/or large open partial bowel resection based on a documented incision size greater than or equal to (≥) 10 cm with primary anastomosis
- Females must not be pregnant as confirmed by a serum pregnancy test at screening and by a urine pregnancy test on the day of surgery
Key exclusion criteria (9 listed)
- Any procedure which requires a diverting stoma
- Primary anastomosis not performed at the time of surgery
- Epidural or intrathecal anesthesia
- Significant liver disease (ALT and/or total bilirubin > 2-fold upper limits of normal) or kidney disease (serum creatinine > 2.5 mg/dL) at screening
- History of irritable bowel syndrome
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 |
|---|---|---|
| Saline Solution for InjectionIntravenous (IV) | Drug | Placebo |
| IpamorelinIntravenous (IV) | Drug | 0.03 mg/kg BID, 0.06 mg/kg BID, 0.06 mg/kg TID |
Primary outcome
Recovery of Gastrointestinal (GI) Function
Time frame: Up to 10 days
To assess the efficacy of three repeated dose levels of ipamorelin vs. placebo
2 secondary outcomes
Ancillary GI Functions
Time frame: Up to 10 days or until hospital discharge
Number of Subjects with Adverse Events as a Measure of Safety and Tolerability
Time frame: 14 day outpatient follow-up visit
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 13 Apr 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
45 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 Saline Solution for Injection and Ipamorelin in people with Gastrointestinal Dysmotility, run by Helsinn Therapeutics (U.S.), Inc at 45 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 6 inclusion and 9 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 13 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 45 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 Gastrointestinal (GI) Function (time frame: Up to 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2017.