Postoperative IleusPhase 2NCT00617552
Safety and Efficacy of IV Infusion of TZP-101 for POI After Major Open Abdominal Surgery
A Phase 2 study testing 5% dextrose in water and TZP-101 in people with Postoperative Ileus, run by Tranzyme, Inc. at 27 sites in 3 countries.
Trial summary
The purpose of this study is to determine whether TZP-101 is effective in the management of post operative ileus in subjects undergoing major open abdominal surgery (i.e. partial large bowel resection). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Ileus
- What is being tested?
- 5% dextrose in water and TZP-101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 267 participants
- Where
- 27 sitesin 3 countries
- Study dates
- Jul 2007to Aug 2008
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who meet all of the following inclusion criteria may be enrolled in the study:
- Male or Female, 18 to 80 years of age, inclusive
- If female, post-menopausal for the past 12 months, surgically sterile (i.e. tubal ligation, hysterectomy), or using an adequate method of birth control (i.e., oral contraceptives, double barrier method, IUD cover or sterilized partner
- Subject is scheduled to undergo a partial large bowel resection with primary anastomosis - See Appendix II
- Subject's body weight is ≤100kg
- Subject is scheduled to receive postoperative pain management with i.v. opioids
Show all 10Show fewer
- Subject is scheduled to have nasogastric tube removed at the end of surgery
- Subject is scheduled to be offered liquids on postoperative day 1
- Subject is scheduled to be encouraged for ambulation on postoperative day 1
- Subject is scheduled to be offered solid food on postoperative day 2
Who cannot join
- Subjects who meet any of the following exclusion criteria may not be enrolled in the study:
- A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450(men)/ >470(women) milliseconds)
- Subject has history of additional risk factors for Torsades de Pointes (heart failure, hypokalemia, family history of Long QT Syndrome)
- Subject requires use of concomitant medication that prolongs the QT interval - List provided in Study Procedures Manual
- Subject requires use of concomitant medication that is a known to interact with isoenzyme CYP3A4
- Subject has complete bowel obstruction
Show all 19Show fewer
- Subject is scheduled to receive a thoracic epidural
- Subject is scheduled to receive total colectomy, colostomy, or ileostomy
- Subject is scheduled to receive a lower anterior resection
- Subject is scheduled for laparoscopic procedure
- Subject is scheduled to receive prophylactic antiemetics post surgery; however subjects may receive intraoperatively as part of the anesthesia protocol and postoperative antiemetics for symptomatic treatment
- Subject has significant impairment of liver or renal function (ALT/AST 2 ½ times the upper limit of normal; creatinine clearance < 50mL/min.)
- Subject has a psychiatric disorder or cognitive impairment that would interfere with participation in the study
- Subject has severe cardiovascular, pulmonary, hematological diseases
- Subject has participated in an investigational study 30 days prior or received TZP-101 90 days prior to the study initiation
- Subject is pregnant (confirmed by quantitative serum pregnancy test) or is breast-feeding
- Subject has a known history of Hep B, Hep C or HIV
- Subject has a known history of drug or alcohol abuse
- Subject has a recent, adult history of clinically significant hypersensitivity reaction(s) to any drug
Trial locations and contacts
27 sites in 3 countries.
27 sites in 3 countries
United States10 sites
Univ. of Maryland, R.A. Cowley Shock Trauma Center
Baltimore, Maryland, 21201
Mid Dakota Clinic, PC
Bismarck, North Dakota, 58501
Northwestern University
Chicago, Illinois, 60611
Michigan State/Spectrum Health
Grand Rapids, Michigan, 49503
The Methodist Hospital
Houston, Texas, 77030
Office of Dr. Phillip Fleshner
Los Angeles, California, 90048
University of Miami Clinic
Miami, Florida, 33136
Renstar Medical Research
Ocala, Florida, 34471
Baystate Medical Center/Baystate Health
Springfield, Massachusetts, 01199
Stony Brook University Hospital
Stony Brook, New York, 11794
Romania9 sites
Clinica de Chirugie General IV, Spitalul Universitar
Bucharest, 00000 RO
Clinica de Chirugie Generala I, Spitalul Universitar
Bucharest, 00000 RO
Clinica de Chirugie Generala III, Spitalul Universitar
Bucharest, 00000 RO
Institul Clinic Fundeni
Bucharest, 00000 RO
Spitalul Clinic Colentina
Bucharest, 00000 RO
Spitalul Clinic Coltea
Bucharest, 00000 RO
Spitalul Clinic de Urgenta Floreasca
Bucharest, 00000 RO
Spitalul Urg. SF. Pantelimon
Bucharest, 021659 RO
Spitalul Universitar Elias
Bucharest
India8 sites
St. John's Hospital
Bangalore, Karnataka
Stanley Medical College
Chennai, 600001
Asian Institute of Gastroenterology
Hyderabad, 500082
Nizams Institute of Medical Science
Hyderabad, 500083
Mediciti Hospitals
Hyderabad, 50063
Amrita Institute of Medical Sciences
Kochi, 682026
Lakeshore Hospital
Kochi, 682304
Sanjay Gandhi Post-Graduate Institute of Medical Sciences
Lucknow, 226014
About this study
Official title: Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess Efficacy and Safety of TZP-101 When Administered as 30 Minute i.v. Infusion for POI to Subjects Undergoing Major Open Abdominal Surgery
The purpose of this study is to determine whether TZP-101 is effective in the management of post operative ileus in subjects undergoing major open abdominal surgery (i.e. partial large bowel resection).
Read the detailed description
Subjects will be randomized according to an adaptive randomization procedure.
- Conditions
- Postoperative Ileus
- Being tested
- 5% dextrose in water, TZP-101
- Keywords
- postoperative ileus, POI, major open abdominal surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% dextrose in waterDrug
Also called D5W
60 ml IV infusion over 30 minutes
TZP-101Drug
20 micrograms/kg IV 2ml/minute for 30 minutes
TZP-101Drug
40 micrograms/kg IV 2 ml/minute for 30 minutes
TZP-101Drug
80 micrograms/kg IV 2ml/minute for 30 minutes
TZP-101Drug
160 micrograms/kg IV 2ml/minute over 30 minutes
TZP-101Drug
320 micrograms/kg IV 2ml/minute for 30 minutes
TZP-101Drug
480 micrograms/kg IV 2ml/minute over 30 minutes
TZP-101Drug
600 micrograms/kg IV 2ml/minute for 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Drug: 5% dextrose in water |
| 2 | Experimental | Not described Receives: Drug: TZP-101 |
| 3 | Experimental | Not described Receives: Drug: TZP-101 |
| 4 | Experimental | Not described Receives: Drug: TZP-101 |
| 5 | Experimental | Not described Receives: Drug: TZP-101 |
| 6 | Experimental | Not described Receives: Drug: TZP-101 |
| 7 | Experimental | Not described Receives: Drug: TZP-101 |
| 8 | Experimental | Not described Receives: Drug: TZP-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to recovery of gastrointestinal function as defined by the time to first bowel movement.
Measured: 7 days of dosing plus 7 days after administration of last dose
Secondary outcomes (1)
time to tolerance of first solid food
Measured: 7 days post administration of last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2008 (estimated)
- Study startJul 2007
- Primary completionJul 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tranzyme, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00617552
- Sponsor's protocol ID
- TZP-101-CL-P005
- Status last verified
- Dec 2012
- First submitted
- 6 Feb 2008
- Last updated
- 7 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess Efficacy and Safety of TZP-101 When Administered as 30 Minute i.v. Infusion for POI to Subjects Undergoing Major Open Abdominal Surgery
- ClinicalTrials.gov ID
- NCT00617552
- Acronym / sponsor ID
- TZP-101-CL-P005
- Conditions
- Postoperative Ileus
- Keywords
- postoperative ileus, POI, major open abdominal surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Tranzyme, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 18 Feb 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 whether TZP-101 is effective in the management of post operative ileus in subjects undergoing major open abdominal surgery (i.e. partial large bowel resection).
Detailed description
Subjects will be randomized according to an adaptive randomization procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: 5% dextrose in water |
| 2 | Experimental | Drug: TZP-101 |
| 3 | Experimental | Drug: TZP-101 |
| 4 | Experimental | Drug: TZP-101 |
| 5 | Experimental | Drug: TZP-101 |
| 6 | Experimental | Drug: TZP-101 |
| 7 | Experimental | Drug: TZP-101 |
| 8 | Experimental | Drug: TZP-101 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or Female, 18 to 80 years of age, inclusive
- If female, post-menopausal for the past 12 months, surgically sterile (i.e. tubal ligation, hysterectomy), or using an adequate method of birth control (i.e., oral contraceptives, double barrier method, IUD cover or sterilized partner
- Subject is scheduled to undergo a partial large bowel resection with primary anastomosis - See Appendix II
- Subject's body weight is ≤100kg
- Subject is scheduled to receive postoperative pain management with i.v. opioids
Key exclusion criteria (19 listed)
- Subjects who meet any of the following exclusion criteria may not be enrolled in the study:
- A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450(men)/ >470(women) milliseconds)
- Subject has history of additional risk factors for Torsades de Pointes (heart failure, hypokalemia, family history of Long QT Syndrome)
- Subject requires use of concomitant medication that prolongs the QT interval - List provided in Study Procedures Manual
- Subject requires use of concomitant medication that is a known to interact with isoenzyme CYP3A4
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 |
|---|---|---|
| 5% dextrose in waterAlso: D5W60 ml IV infusion over 30 minutes | Drug | 1 |
| TZP-10120 micrograms/kg IV 2ml/minute for 30 minutes | Drug | 2 |
| TZP-10140 micrograms/kg IV 2 ml/minute for 30 minutes | Drug | 3 |
| TZP-10180 micrograms/kg IV 2ml/minute for 30 minutes | Drug | 4 |
| TZP-101160 micrograms/kg IV 2ml/minute over 30 minutes | Drug | 5 |
| TZP-101320 micrograms/kg IV 2ml/minute for 30 minutes | Drug | 6 |
| TZP-101480 micrograms/kg IV 2ml/minute over 30 minutes | Drug | 7 |
| TZP-101600 micrograms/kg IV 2ml/minute for 30 minutes | Drug | 8 |
Primary outcome
Time to recovery of gastrointestinal function as defined by the time to first bowel movement.
Time frame: 7 days of dosing plus 7 days after administration of last dose
1 secondary outcome
time to tolerance of first solid food
Time frame: 7 days post administration of last dose
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 7 Dec 2012.
Related trials for Postoperative Ileus
Recruiting
Rectus Sheath Catheters Following Midline Laparotomy
Acute Abdomen, Ileus
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
At-Home Bowel Stimulation
Post-Operative Ileus (POI)
Recruiting
The Food Network Effect
Post Operative Patients
RecruitingPhase 4
Effect of Tegileridine on Postoperative Bowel Function Recovery in Abdominal Surgery
Pain, Postoperative, Postoperative Ileus
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.
27 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 5% dextrose in water and TZP-101 in people with Postoperative Ileus, run by Tranzyme, Inc. at 27 sites in 3 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 10 inclusion and 19 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 7 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, Romania, India. 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?
Time to recovery of gastrointestinal function as defined by the time to first bowel movement. (time frame: 7 days of dosing plus 7 days after administration of last dose). 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 7 Dec 2012.