GastroparesisPhase 2NCT00889486
Safety and Efficacy of Once-daily Oral Administrations of TZP-102 for Gastroparesis in Patients With Diabetes Mellitus
A Phase 2 study testing TZP-102 in people with Gastroparesis and Diabetes Mellitus, run by Tranzyme, Inc. at 23 sites in 6 countries.
Trial summary
The purpose of this study is to evaluate the effect of TZP-102 on gastric emptying rate, gastroparesis symptoms and health-related quality of life in diabetic patients with gastroparesis. 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?
- TZP-102
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 23 sitesin 6 countries
- Study dates
- Apr 2009to Apr 2010
- 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
- 18 to 80 years of age, inclusive.
- Type 1 or type 2 diabetes mellitus.
- Female patients of childbearing potential must have a negative serum pregnancy test and use (and agree to continue to use throughout the study) an acceptable method of contraception.
- HbA1c level less than/equal to 10.0 % at the Screening Visit.
- Diagnosis of gastroparesis including (all three of the following requirements apply): i. Documented delayed gastric emptying; ii. A greater than 3 month history of symptoms of gastroparesis; iii. A GCSI Total Score greater than/equal to 2.66 at the Screening Visit and greater than/equal to 1.90 at the Day 1 visit.
- Upper gastrointestinal obstruction ruled out by endoscopy or barium scan.
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- Concomitant medications must be stable for at least 2 weeks leading up to the Baseline Visit and be maintained during the study.
- Body Mass Index (BMI) < 35.
- Delayed gastric emptying by breath test demonstrated at the Baseline Visit.
Who cannot join
- Persistent daily vomiting
- Gastrectomy, obesity surgery, fundoplication, or vagotomy/pyloroplasty.
- Pyloric Botox within 6 months prior to Screening Visit.
- NG, PEG or PEJ feeding tube.
- Required in-patient hospitalization for treatment of gastroparesis within 2 weeks prior to the Screening Visit.
- Parenteral nutrition for treatment of gastroparesis within 2 months prior to the Screening Visit.
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- Active gastric pacemaker within 3 months prior to the Screening Visit.
- Participation in an investigational study within 30 days prior to study entry.
- Chronic severe diarrhea.
- Diabetic ketoacidosis requiring hospitalization within 30 days prior to study entry.
- History of any eating disorder within 2 years prior to study entry.
- Significant chronic obstructive pulmonary disease or chronic asthma.
- Patient is a heavy smoker, and/or unable or unwilling to abstain from smoking during each of the three study visits during which the gastric emptying breath tests will be performed.
- History of risk factors for Torsades de Pointes.
- Patient requires treatment with certain concomitant medications known to have a clinically recognized risk for Torsades de Pointes.
- History of acute myocardial infarction (MI) or unstable angina within 12 months prior to study entry.
- History of any psychiatric disorder or cognitive impairment that would interfere with participation in the study.
- History of alcohol dependency within 2 years prior to study entry.
- Taking opiates for abdominal pain.
- History of HIV infection.
- History of Hepatitis B or C currently exhibiting symptoms expected to worsen during course of study.
- Requires dialysis or has severely impaired renal function.
- Severe impairment of liver function.
- Uncontrolled hypo- or hyperthyroidism.
- History of adrenal insufficiency.
- Pregnant or is breast-feeding.
- Allergic to or intolerant of wheat, egg, soy or milk products.
- Patient requires a gluten-free diet.
- Any other medical condition or social circumstance that, in the investigator's opinion, makes it inappropriate for the patient to participate in this clinical trial.
Trial locations and contacts
23 sites in 6 countries.
23 sites in 6 countries
United States11 sites
Saint John's Research Institute
Anderson, Indiana, 46012
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Texas Tech Univ. Health Sciences Center Dept. of Medicine
El Paso, Texas, 79905
University of Kansas Medical Center
Kansas City, Kansas, 66160
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Long Beach VA Medical Center
Long Beach, California, 90822
Impact Clinical Trials
Los Angeles, California, 90036
Univ. of Louisville Medical-Dental Complex
Louisville, Kentucky, 40202
Wake Research Associates
Raleigh, North Carolina, 27612
California Pacific Medical Center Research Institute
San Francisco, California, 94115
University of South Florida/Tampa General Hospital
Tampa, Florida, 33606
Denmark4 sites
Aalborg Hospital
Aalborg
Aarhus University Hospital
Aarhus
Steno Diabetes Center
Gentofte Municipality
Odense University Hospital
Odense
Poland3 sites
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok
Oddzial Kliniczny Diabetologii Samodzielny Publiczny Zaklad
Lodz
Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie
Warsaw
United Kingdom3 sites
Ipswich Hospital NHS Trust
Ipswich
Leicester Royal Infirmary
Leicester
Wellcome Truest Clinical Research Facility
Manchester
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Evaluation of the Safety and Efficacy of Once-Daily Administrations of TZP 102 for the Treatment of Symptomatic Gastroparesis in Patients With Diabetes Mellitus
The purpose of this study is to evaluate the effect of TZP-102 on gastric emptying rate, gastroparesis symptoms and health-related quality of life in diabetic patients with gastroparesis.
- Conditions
- Gastroparesis, Diabetes Mellitus
- Being tested
- TZP-102, Placebo
- Keywords
- gastroparesis, diabetes mellitus, delayed gastric emptying
- 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.
TZP-102Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Four placebo capsules taken orally once per day for 28 days Receives: Drug: Placebo |
| 10 mg TZP-102 | Experimental | One 10 mg TZP-102 Capsule and three placebo capsules taken orally once per day for 28 days Receives: Drug: TZP-102; Drug: Placebo |
| 20 mg TZP-102 | Experimental | Two 10 mg TZP-102 Capsules and two placebo capsules taken orally once per day for 28 days Receives: Drug: TZP-102; Drug: Placebo |
| 40 mg TZP-102 | Experimental | Four 10 mg TZP-102 Capsules taken orally once per day for 28 days Receives: Drug: TZP-102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in gastric half-emptying time
Measured: study days 1 and 28
Secondary outcomes (1)
change from baseline in gastroparesis symptoms and health-related quality of life
Measured: study days 8, 15 and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionApr 2010
- Study completionApr 2010
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
- 92 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
- NCT00889486
- Sponsor's protocol ID
- TZP-102-CL-G002
- Status last verified
- Dec 2012
- First submitted
- 28 Apr 2009
- Last updated
- 11 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Evaluation of the Safety and Efficacy of Once-Daily Administrations of TZP 102 for the Treatment of Symptomatic Gastroparesis in Patients With Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00889486
- Acronym / sponsor ID
- TZP-102-CL-G002
- Conditions
- Gastroparesis, Diabetes Mellitus
- Keywords
- gastroparesis, diabetes mellitus, delayed gastric emptying
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Tranzyme, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 29 Apr 2009 (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 evaluate the effect of TZP-102 on gastric emptying rate, gastroparesis symptoms and health-related quality of life in diabetic patients with gastroparesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboFour placebo capsules taken orally once per day for 28 days |
| 10 mg TZP-102 | Experimental | Drug: TZP-102, Drug: PlaceboOne 10 mg TZP-102 Capsule and three placebo capsules taken orally once per day for 28 days |
| 20 mg TZP-102 | Experimental | Drug: TZP-102, Drug: PlaceboTwo 10 mg TZP-102 Capsules and two placebo capsules taken orally once per day for 28 days |
| 40 mg TZP-102 | Experimental | Drug: TZP-102Four 10 mg TZP-102 Capsules taken orally once per day for 28 days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 to 80 years of age, inclusive.
- Type 1 or type 2 diabetes mellitus.
- Female patients of childbearing potential must have a negative serum pregnancy test and use (and agree to continue to use throughout the study) an acceptable method of contraception.
- HbA1c level less than/equal to 10.0 % at the Screening Visit.
- Diagnosis of gastroparesis including (all three of the following requirements apply): i. Documented delayed gastric emptying; ii. A greater than 3 month history of symptoms of gastroparesis; iii. A GCSI Total Score greater than/equal to 2.66 at the Screening Visit and greater than/equal to 1.90 at the Day 1 visit.
Key exclusion criteria (29 listed)
- Persistent daily vomiting
- Gastrectomy, obesity surgery, fundoplication, or vagotomy/pyloroplasty.
- Pyloric Botox within 6 months prior to Screening Visit.
- NG, PEG or PEJ feeding tube.
- Required in-patient hospitalization for treatment of gastroparesis within 2 weeks prior to the Screening Visit.
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 |
|---|---|---|
| TZP-102 | Drug | 10 mg TZP-102, 20 mg TZP-102, 40 mg TZP-102 |
| Placebo | Drug | 10 mg TZP-102, 20 mg TZP-102, Placebo |
Primary outcome
change from baseline in gastric half-emptying time
Time frame: study days 1 and 28
1 secondary outcome
change from baseline in gastroparesis symptoms and health-related quality of life
Time frame: study days 8, 15 and 28
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 11 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.
23 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 TZP-102 in people with Gastroparesis and Diabetes Mellitus, run by Tranzyme, Inc. at 23 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 9 inclusion and 29 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 11 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 23 sites in United States, Denmark, Poland, United Kingdom, 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 gastric half-emptying time (time frame: study days 1 and 28). 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 11 Dec 2012.