Gastrointestinal DysmotilityPhase 3NCT01296620
Ulimorelin Study of Efficacy and Safety (ULISES 008)
A Phase 3 study testing Ulimorelin Intravenously (IV), Ulimorelin Invtravenously (IV) and 5% dextrose in water in people with Gastrointestinal Dysmotility, run by Tranzyme, Inc. at 50 sites in 6 countries.
Trial summary
Post-operative administration of ulimorelin is expected to reduce time to recovery of Gastrointestinal (GI) function in patients who have undergone partial large bowel resection Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastrointestinal Dysmotility
- What is being tested?
- Ulimorelin Intravenously (IV), Ulimorelin Invtravenously (IV) and 5% dextrose in water
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 330 participants
- Where
- 50 sitesin 6 countries
- Study dates
- Feb 2011to Mar 2012
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women, 18 to 80 years of age, inclusive
- Scheduled to undergo open bowel resection with colonic anastomosis
- For women who can potentially become pregnant a pregnancy test at screening and admission must be negative
Who cannot join
- Weight more than 200kg (441 pounds)
- Pregnant or breastfeeding
- Known history of drug or alcohol abuse within the previous year
Trial locations and contacts
50 sites in 6 countries.
50 sites in 6 countries
United States26 sites
Tufts Medical Center
Boston, Massachusetts, 02111
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Kaiser Permanente Northwest
Clackamas, Oregon, 34452
Texas Tech University Health Sciences Center
El Paso, Texas, 79905
Sanford Medical Center
Fargo, North Dakota, 58122
Glendale Memorial Hospital
Glendale, California, 91204
Southwest Surgical Associates
Houston, Texas, 77074
Citrus Memorial Hospital
Inverness, Florida, 34452
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
CRC of Jackson
Jackson, Mississippi, 39202
Long Beach Memorial Medical Center
Long Beach, California, 90806
Univ. of Southern California
Los Angeles, California, 90033
Cedars Sinai Medical Center
Los Angeles, California, 90048
Forbes Regional Hospita
Monroeville, Pennsylvania, 15146
Access Clinical Trials, Inc.
Nashville, Tennessee, 37203
NOLA CVT Surgery
New Orleans, Louisiana, 70115
Mount Sinai Hospital
New York, New York, 10021
Palo Alto VA Health Care Ctr
Palo Alto, California, 94304
Pensacola Research Consultants
Pensacola, Florida, 32504
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
VA Pittsburgh Health Care System
Pittsburgh, Pennsylvania, 15241
Oregon Health and Science University
Portland, Oregon, 97239
ARS Clinical Trials
Powder Springs, Georgia, 30127
VCU Medical Center
Richmond, Virginia, 23219
MultiCare Research Institute
Tacoma, Washington, 98405
Tampa General Hospital
Tampa, Florida, 33606
Czechia7 sites
FN Brno
Brno
St. Anne's University Hospital
Brno
Hospital Jihlava
Jihlava
Hospital Liberec
Liberec
FN Olomouc
Olomouc
Fakutni Thomayerova nemocnica
Prague
University Hospital Bulovka
Prague
Lithuania6 sites
Kaunas Clinical Hospital No. 2
Kaunas, LT-47144
Kaunas Medical University Clinics
Kaunas, LT50009
Republican Klaipeda Hospital
Klaipėda, LT-92231
Klaipeda Hospital
Klaipėda, LT-92288
Institute of Oncology at Vilnius University, Clinic of Surgery
Vilnius, LT-08660
Vilnius City Univ. Hospital Clinic of Surgery
Vilnius, LT-10207
Bulgaria5 sites
UMHAT Emergency Medicine
Sifua
MHAT Tokuda Hospital Sofia
Sofia
Military Medical Academy
Sofia
UMHAT Tzaritza Yoanna ISUL
Sofia
UMHAT St. Marina
Varna
France4 sites
CHU Avicenne
Bobigny
Hopital Beaujon
Clichy Paris
CHRU Lille
Lille
CHU Rouen, Hopital Charles Nicolle
Rouen
Romania2 sites
Institute regional de Gastroenterologie si Hepatologie
Cluj-Napoca
Spitalul Clinic Judetean de Urgenta
Oradea
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Intravenous (IV) Ulimorelin Administered Post-Operatively to Accelerate Recovery of Gastrointestinal (GI) Motility in Subjects Who Have Undergone Partial Bowel Resection
Post-operative administration of ulimorelin is expected to reduce time to recovery of Gastrointestinal (GI) function in patients who have undergone partial large bowel resection
- Conditions
- Gastrointestinal Dysmotility
- Being tested
- Ulimorelin Intravenously (IV), Ulimorelin Invtravenously (IV), 5% dextrose in water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ulimorelin Intravenously (IV)Drug
160 µg/kg daily (QD)
Ulimorelin Invtravenously (IV)Drug
480 µg/kg daily (QD)
5% dextrose in waterDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Experimental 1 | Experimental | Not described Receives: Drug: Ulimorelin Intravenously (IV) |
| Experimental 2 | Experimental | Not described Receives: Drug: Ulimorelin Invtravenously (IV) |
| Placebo | Placebo comparator | Not described Receives: Drug: 5% dextrose in water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery of GI Function
Measured: up to 7 days of dosing or until hospital discharge
Secondary outcomes (1)
Ancillary GI Functions
Measured: up to 7 days of dosing or hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionMar 2012
- Study completionMar 2012
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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tranzyme, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Norgine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01296620
- Sponsor's protocol ID
- TZP-101-CL-P008
- Other IDs
- 2010-023229-38
- Status last verified
- Jul 2012
- First submitted
- 14 Feb 2011
- Last updated
- 26 Jul 2012
- Results posted
- No
Publications
Shaw M, Pediconi C, McVey D, Mondou E, Quinn J, Chamblin B, Rousseau F. Safety and efficacy of ulimorelin administered postoperatively to accelerate recovery of gastrointestinal motility following partial bowel resection: results of two randomized, placebo-controlled phase 3 trials. Dis Colon Rectum. 2013 Jul;56(7):888-97. doi: 10.1097/DCR.0b013e31829196d0.
PubMed 23739196
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Intravenous (IV) Ulimorelin Administered Post-Operatively to Accelerate Recovery of Gastrointestinal (GI) Motility in Subjects Who Have Undergone Partial Bowel Resection
- ClinicalTrials.gov ID
- NCT01296620
- Acronym / sponsor ID
- TZP-101-CL-P008
- Conditions
- Gastrointestinal Dysmotility
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Tranzyme, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Norgine
- Study start
- Feb 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 15 Feb 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 ulimorelin is expected to reduce time to recovery of Gastrointestinal (GI) function in patients who have undergone partial large bowel resection
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental 1 | Experimental | Drug: Ulimorelin Intravenously (IV) |
| Experimental 2 | Experimental | Drug: Ulimorelin Invtravenously (IV) |
| Placebo | Placebo comparator | Drug: 5% dextrose in water |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men or women, 18 to 80 years of age, inclusive
- Scheduled to undergo open bowel resection with colonic anastomosis
- For women who can potentially become pregnant a pregnancy test at screening and admission must be negative
Key exclusion criteria (3 listed)
- Weight more than 200kg (441 pounds)
- Pregnant or breastfeeding
- Known history of drug or alcohol abuse within the previous year
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 |
|---|---|---|
| Ulimorelin Intravenously (IV)160 µg/kg daily (QD) | Drug | Experimental 1 |
| Ulimorelin Invtravenously (IV)480 µg/kg daily (QD) | Drug | Experimental 2 |
| 5% dextrose in waterPlacebo | Drug | Placebo |
Primary outcome
Recovery of GI Function
Time frame: up to 7 days of dosing or until hospital discharge
1 secondary outcome
Ancillary GI Functions
Time frame: up to 7 days of dosing or 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 26 Jul 2012.
- Derived from this study: PubMed 23739196Shaw M, Pediconi C, McVey D, Mondou E, Quinn J, Chamblin B, Rousseau F. Safety and efficacy of ulimorelin administered postoperatively to accelerate recovery of gastrointestinal motility following partial bowel resection: results of two randomized, placebo-controlled phase 3 trials. Dis Colon Rectum. 2013 Jul;56(7):888-97. doi: 10.1097/DCR.0b013e31829196d0.
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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.
50 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ulimorelin Intravenously (IV), Ulimorelin Invtravenously (IV) and 5% dextrose in water in people with Gastrointestinal Dysmotility, run by Tranzyme, Inc. at 50 sites in 6 countries.
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 3 inclusion and 3 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 26 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in United States, Czechia, Lithuania, Bulgaria, France and 1 more country. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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: up to 7 days of dosing or 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 NCT01296620, 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 26 Jul 2012.