GastroparesisPhase 2NCT00612014
Safety and Efficacy of IV Infusion of Investigational Agent (TZP-101) in Patients With Severe Diabetic Gastroparesis
A Phase 2 study testing 5% dextrose in water and TZP-101 in people with Gastroparesis and Diabetes Mellitus, run by Tranzyme, Inc. at 12 sites in 6 countries.
Trial summary
The purpose of this study is to determine whether TZP-101 is effective in the treatment of symptomatic gastroparesis due to diabetes. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastroparesis, Diabetes Mellitus
- 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
- 78 participants
- Where
- 12 sitesin 6 countries
- Study dates
- Oct 2007to Mar 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has type 1 or type 2 diabetes mellitus
- Subject has documented diagnosis of gastroparesis (all of the following apply):
- Confirmed delayed gastric emptying (see Appendix IV; properly conducted gastric emptying assessments within last 6 months acceptable)
- AND a minimum 3 month history of relevant symptoms for gastroparesis (chronic postprandial fullness, bloating, epigastric discomfort, early satiety, belching after meal, postprandial nausea, vomiting).
- AND a mean Gastroparesis Cardinal Symptom Index (GCSI) Score (2 week recall version) of ≥ 2.66
- AND it is confirmed by endoscope that there are no obstructive lesions in the esophagus or stomach (endoscopy within prior 3 months acceptable)
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- Subject has never had a gastrectomy, nor major abdominal surgery or any evidence of bowel obstruction within the previous 12 months
- Dosage of any concomitant medications has been stable for at least 3 weeks
- HbA1c level is ≤ 10.0%
- Subject has a BMI < 30
- Subject body weight is ≤ 100 kg
- 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
Who cannot join
- Subject has acute severe gastroenteritis
- Subject has a gastric pacemaker
- Subject is on chronic parenteral feeding
- Subject has daily persistent severe vomiting
- Subject has pronounced dehydration
- Subject has had diabetic ketoacidosis in last 4 weeks
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- Subject has a history of eating disorders (anorexia nervosa, binge eating, bulimia)
- Subject has a marked baseline prolongation of QT/QTc interval (repeated demonstration of a QTc interval >450 ms for male / >470 ms for female)
- Subject has a history of additional risk factors for Torsades de Pointes (heart failure, chronic hypokalemia, family history of Long QT Syndrome)
- Subject requires use of concomitant medication that prolongs the QT interval
- List provided to clinical sites
- Subject has history of cardiovascular ischemia in previous 12 months or acute myocardial infarction (MI) or unstable angina
- Subject requires use of concomitant medication that is known to interact with isoenzyme CYP3A4 and the combination with an CYP3A4 inhibitor is known to introduce a clinically significant drug interaction
- List provided to clinical sites
- Subject has a history of psychiatric disorder or cognitive impairment that would interfere with participation in the study
- Subject has a history of alcoholism
- Subject is taking regular daily narcotics
- Subject has a known history of Hep B, Hep C or HIV
- Subject has severely impaired renal function (creatinine clearance < 30 mL/min)
- Subject has severe impairment of liver function, defined as albumin level ≤ 2.5 gm/dL and/or prothrombin time >6 seconds over control (INR > 2.3)
- Subject has participated in an investigational study within 30 days prior to or received TZP-101 within 90 days prior to study initiation
- Subject is pregnant or is breast-feeding
Trial locations and contacts
12 sites in 6 countries.
12 sites in 6 countries
United States6 sites
Central Indiana Gastroenterology Group
Anderson, Indiana, 46016-4346
Massachusetts General Hospital
Boston, Massachusetts, 02114
Kansas University Medical Center
Kansas City, Kansas, 66160
University of Louisville
Louisville, Kentucky, 40202
California Pacific Medical Center
San Francisco, California, 94115
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
United Kingdom2 sites
Manchester Royal Infirmary
Manchester, M139WL
Royal Hallamshire Hospital
Sheffield, S102JF
India1 site
Amrita Institute of Medical Sciences Research Center (AIMS)
Kochi, Kerala, 682026
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-ranging Study to Assess the Efficacy and Safety of TZP-101 When Administered as a 30 Minute I.V. Infusion to Subjects With Severe Gastroparesis Due to Diabetes Mellitus
The purpose of this study is to determine whether TZP-101 is effective in the treatment of symptomatic gastroparesis due to diabetes.
Read the detailed description
Subjects are randomized according to an adaptive randomization procedure.
- Conditions
- Gastroparesis, Diabetes Mellitus
- Being tested
- 5% dextrose in water, TZP-101
- Keywords
- delayed gastric emptying, symptomatic gastroparesis, diabetes mellitus
- Medical subject headings
- Gastroparesis, Diabetes Mellitus
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
40 micrograms/kg iv 2ml/minute for 30 minutes
1 infusion/day for 4 consecutive days
TZP-101Drug
80 micrograms/kg iv 2ml/minute for 30 minutes
1 infusion/day for 4 consecutive days
TZP-101Drug
160 micrograms/kg iv 2ml/minute for 30 minutes
1 infusion/day for 4 consecutive days
TZP-101Drug
320 micrograms/kg iv 2ml/minute for 30 minutes
1 infusion/day for 4 consecutive days
TZP-101Drug
600 micrograms/kg iv 2ml/minute for 30 minutes
1 infusion/day for 4 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Drug: 5% dextrose in water |
| 2 | Experimental | 40 micrograms/kg Receives: Drug: TZP-101 |
| 3 | Experimental | 80 micrograms/kg Receives: Drug: TZP-101 |
| 4 | Experimental | 160 micrograms/kg Receives: Drug: TZP-101 |
| 5 | Experimental | 320 microgram/kg Receives: Drug: TZP-101 |
| 6 | Experimental | 600 microgram/kg Receives: Drug: TZP-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the mean Gastroparesis Cardinal Symptom Index score (24 hour recall version) across the four days of dosing. Baseline is the average of the scores collected across the 4 days just prior to admission for dosing.
Measured: after 4 dosing days
Secondary outcomes (1)
Cumulative GSA score after each dosing event and after all dosing events
Measured: every 30 minutes for 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2008 (estimated)
- Study startOct 2007
- Primary completionFeb 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroparesisStudies 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
- 78 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
- NCT00612014
- Sponsor's protocol ID
- TZP-101-CL-G004
- Other IDs
- 2007-003279-38
- Status last verified
- Dec 2012
- First submitted
- 28 Jan 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
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-ranging Study to Assess the Efficacy and Safety of TZP-101 When Administered as a 30 Minute I.V. Infusion to Subjects With Severe Gastroparesis Due to Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00612014
- Acronym / sponsor ID
- TZP-101-CL-G004
- Conditions
- Gastroparesis, Diabetes Mellitus
- Keywords
- delayed gastric emptying, symptomatic gastroparesis, diabetes mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Tranzyme, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 11 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 treatment of symptomatic gastroparesis due to diabetes.
Detailed description
Subjects are 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
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: 5% dextrose in water |
| 2 | Experimental | Drug: TZP-10140 micrograms/kg |
| 3 | Experimental | Drug: TZP-10180 micrograms/kg |
| 4 | Experimental | Drug: TZP-101160 micrograms/kg |
| 5 | Experimental | Drug: TZP-101320 microgram/kg |
| 6 | Experimental | Drug: TZP-101600 microgram/kg |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subject has type 1 or type 2 diabetes mellitus
- Subject has documented diagnosis of gastroparesis (all of the following apply):
- Subject has never had a gastrectomy, nor major abdominal surgery or any evidence of bowel obstruction within the previous 12 months
- Dosage of any concomitant medications has been stable for at least 3 weeks
- HbA1c level is ≤ 10.0%
Key exclusion criteria (22 listed)
- Subject has acute severe gastroenteritis
- Subject has a gastric pacemaker
- Subject is on chronic parenteral feeding
- Subject has daily persistent severe vomiting
- Subject has pronounced dehydration
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-10140 micrograms/kg iv 2ml/minute for 30 minutes 1 infusion/day for 4 consecutive days | Drug | 2 |
| TZP-10180 micrograms/kg iv 2ml/minute for 30 minutes 1 infusion/day for 4 consecutive days | Drug | 3 |
| TZP-101160 micrograms/kg iv 2ml/minute for 30 minutes 1 infusion/day for 4 consecutive days | Drug | 4 |
| TZP-101320 micrograms/kg iv 2ml/minute for 30 minutes 1 infusion/day for 4 consecutive days | Drug | 5 |
| TZP-101600 micrograms/kg iv 2ml/minute for 30 minutes 1 infusion/day for 4 consecutive days | Drug | 6 |
Primary outcome
Change from baseline in the mean Gastroparesis Cardinal Symptom Index score (24 hour recall version) across the four days of dosing. Baseline is the average of the scores collected across the 4 days just prior to admission for dosing.
Time frame: after 4 dosing days
1 secondary outcome
Cumulative GSA score after each dosing event and after all dosing events
Time frame: every 30 minutes for 4 hours
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.
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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.
12 sites in 6 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 Gastroparesis and Diabetes Mellitus, run by Tranzyme, Inc. at 12 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 12 inclusion and 22 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 12 sites in United States, United Kingdom, Denmark, India, Norway 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 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?
Change from baseline in the mean Gastroparesis Cardinal Symptom Index score (24 hour recall version) across the four days of dosing. Baseline is the average of the scores collected across the 4 days just prior to admission for dosing. (time frame: after 4 dosing 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 7 Dec 2012.