Diabetic GastroparesisPhase 2DIGESTNCT01664637
Diabetic Gastroparesis Efficacy/Safety Study of TZP-102
A Phase 2 study testing 10 mg TZP-102 in people with Diabetic Gastroparesis, run by Tranzyme, Inc. at 35 sites in 2 countries.
Trial summary
The purpose of this study is to test the safety and effectiveness of 10 mg TZP-102 given prior to meals three times a day compared to placebo (capsule that looks like active study drug but contains no active drug), administered for 12 weeks, in diabetic subjects with symptoms associated with gastroparesis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Gastroparesis
- What is being tested?
- 10 mg TZP-102
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 35 sitesin 2 countries
- Study dates
- Aug 2012to Feb 2013
- 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
- History of symptoms of gastroparesis for at least 3 months leading up to the Screening Visit
- Documented delayed gastric emptying
- Upper gastrointestinal obstruction ruled out by endoscopy or barium scan
- Concomitant medications must be stable for at least 2 weeks leading up to the Screening visit and must be maintained during the study.
- Females of child-bearing potential must have a negative serum pregnancy test and use (and agree to continue to use throughout the study) an acceptable form of contraception
Who cannot join
- Gastrectomy, bariatric surgery, fundoplication or vagotomy/pyloroplasty
- Has had or plans to have endoscopic pyloric injections of botulinum toxin within 6 months prior to the Screening Visit or during the study
- NG, PEG or PEJ feeding tube or inpatient hospitalization for gastroparesis within 2 weeks prior to the Screening Visit
- Required parenteral nutrition for treatment of gastroparesis within 2 months prior to the Screening Visit
- Active gastric pacemaker within 3 months prior to the Screening Visit
Trial locations and contacts
35 sites in 2 countries.
35 sites in 2 countries
United States23 sites
Tranzyme Investigational Site
Anderson, Indiana, 46106
Tranzyme Investigational Site
Boston, Massachusetts, 02215
Tranzyme Investigational Site
El Paso, Texas, 79905
Tranzyme Investigational Site
Hialeah, Florida, 33016
Tranzyme Investigational Site
Huntsville, Alabama, 35801
Tranzyme Investigational Site
Indianapolis, Indiana, 46202
Tranzyme Investigational Site
Inverness, Florida, 34452
Tranzyme Investigational Site
Jacksonville, Florida, 32256
Tranzyme Investigational Site
Kansas City, Kansas, 66160
Tranzyme Investigational Site
Long Beach, California, 90822
Tranzyme Investigational Site
Mexico, Missouri, 65265
Tranzyme Investigational Site
Miami, Florida, 33144
Tranzyme Investigational Site
Miami, Florida, 33183
Tranzyme Investigational Site
Monroe, Louisiana, 71201
Tranzyme Investigational Site
New Smyrna Beach, Florida, 32168
Tranzyme Investigational Site
North Little Rock, Arkansas, 72117
Tranzyme Investigational Site
Oklahoma City, Oklahoma, 73104
Tranzyme Investigational Site
Portland, Oregon, 97210
Tranzyme Investigational Site
Raleigh, North Carolina, 27612
Tranzyme Investigational Site
Salisbury, North Carolina, 28144
Tranzyme Investigational Site
Tucson, Arizona, 85710
Tranzyme Investigational Site
Ventura, California, 93003
Tranzyme Investigational Site
Winston-Salem, North Carolina, 27103
Poland12 sites
Tranzyme Investigational Site
Bialystok, 15732
Tranzyme Investigational Site
Bialystok, 15950
Tranzyme Investigational Site
Bydgoszcz, 85094
Tranzyme Investigational Site
Kielce, 25035
Tranzyme Investigational Site
Krakow, 31530
Tranzyme Investigational Site
Lodz, 90251
Tranzyme Investigational Site
Lublin, 20090
Tranzyme Investigational Site
Lublin, 20607
Tranzyme Investigational Site
Olsztyn, 10561
Tranzyme Investigational Site
Rzeszów, 35073
Tranzyme Investigational Site
Warsaw, 02097
Tranzyme Investigational Site
Zgierz, 95100
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Evaluation of the Efficacy and Safety of TZP-102 Given Orally Three Times a Day for the Treatment of Symptoms Associated With Diabetic Gastroparesis
The purpose of this study is to test the safety and effectiveness of 10 mg TZP-102 given prior to meals three times a day compared to placebo (capsule that looks like active study drug but contains no active drug), administered for 12 weeks, in diabetic subjects with symptoms associated with gastroparesis.
- Conditions
- Diabetic Gastroparesis
- Being tested
- 10 mg TZP-102, Placebo
- Keywords
- diabetic gastroparesis, delayed gastric emptying, gastroparesis, diabetes mellitus, Type 1, diabetes mellitus, Type 2
- Medical subject headings
- Gastroparesis, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 mg TZP-102Drug
One oval-shaped, opaque-white, hard gelatin capsule containing active ingredient will be taken orally three times a day for 12 weeks
PlaceboDrug
One oval-shaped, opaque-white, hard gelatin capsule of placebo indistinguishable from active drug will be taken orally three times a day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| TZP-102 three times a day | Experimental | 10 mg TZP-102 will be taken 30 minutes prior to each main meal for a total of three daily doses. Receives: Drug: 10 mg TZP-102 |
| Placebo three times a day | Placebo comparator | Placebo will be taken 30 minutes prior to each main meal for a total of three daily doses. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in symptoms associated with diabetic gastroparesis
Measured: 12 Weeks
Secondary outcomes (2)
Change from baseline in health-related quality of life
Measured: 12 Weeks
Adverse events (AEs), vital signs, ECGs, clinical laboratory parameters
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionJan 2013 (estimated)
- Study completionFeb 2013 (estimated)
Why it stopped: Insufficient efficacy in planned interim futility analysis
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 Diabetic 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tranzyme, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elsa Mondou, M.D., Study director, Tranzyme, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01664637
- Sponsor's protocol ID
- TZP-102-CL-G004
- Acronym
- DIGEST
- Status last verified
- Dec 2012
- First submitted
- 10 Aug 2012
- Last updated
- 20 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
McCallum RW, Lembo A, Esfandyari T, Bhandari BR, Ejskjaer N, Cosentino C, Helton N, Mondou E, Quinn J, Rousseau F; TZP-102 Phase 2b Study Group. Phase 2b, randomized, double-blind 12-week studies of TZP-102, a ghrelin receptor agonist for diabetic gastroparesis. Neurogastroenterol Motil. 2013 Nov;25(11):e705-17. doi: 10.1111/nmo.12184. Epub 2013 Jul 15.
PubMed 23848826
Study at a glance
From the registry record, last updated by the sponsor on 20 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 Evaluation of the Efficacy and Safety of TZP-102 Given Orally Three Times a Day for the Treatment of Symptoms Associated With Diabetic Gastroparesis
- ClinicalTrials.gov ID
- NCT01664637
- Acronym / sponsor ID
- DIGEST / TZP-102-CL-G004
- Conditions
- Diabetic Gastroparesis
- Keywords
- diabetic gastroparesis, delayed gastric emptying, gastroparesis, diabetes mellitus, Type 1, diabetes mellitus, Type 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient efficacy in planned interim futility analysis
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Tranzyme, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Feb 2013 (estimated)
- First posted
- 14 Aug 2012 (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 test the safety and effectiveness of 10 mg TZP-102 given prior to meals three times a day compared to placebo (capsule that looks like active study drug but contains no active drug), administered for 12 weeks, in diabetic subjects with symptoms associated with gastroparesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TZP-102 three times a day | Experimental | Drug: 10 mg TZP-10210 mg TZP-102 will be taken 30 minutes prior to each main meal for a total of three daily doses. |
| Placebo three times a day | Placebo comparator | Drug: PlaceboPlacebo will be taken 30 minutes prior to each main meal for a total of three daily doses. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 to 80 years of age inclusive
- Type 1 or type 2 diabetes mellitus
- History of symptoms of gastroparesis for at least 3 months leading up to the Screening Visit
- Documented delayed gastric emptying
- Upper gastrointestinal obstruction ruled out by endoscopy or barium scan
Key exclusion criteria (5 listed)
- Gastrectomy, bariatric surgery, fundoplication or vagotomy/pyloroplasty
- Has had or plans to have endoscopic pyloric injections of botulinum toxin within 6 months prior to the Screening Visit or during the study
- NG, PEG or PEJ feeding tube or inpatient hospitalization for gastroparesis within 2 weeks prior to the Screening Visit
- Required parenteral nutrition for treatment of gastroparesis within 2 months prior to the Screening Visit
- Active gastric pacemaker within 3 months 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 |
|---|---|---|
| 10 mg TZP-102One oval-shaped, opaque-white, hard gelatin capsule containing active ingredient will be taken orally three times a day for 12 weeks | Drug | TZP-102 three times a day |
| PlaceboOne oval-shaped, opaque-white, hard gelatin capsule of placebo indistinguishable from active drug will be taken orally three times a day for 12 weeks | Drug | Placebo three times a day |
Primary outcome
Change from baseline in symptoms associated with diabetic gastroparesis
Time frame: 12 Weeks
2 secondary outcomes
Change from baseline in health-related quality of life
Time frame: 12 Weeks
Adverse events (AEs), vital signs, ECGs, clinical laboratory parameters
Time frame: 12 Weeks
Results and safety
The study was stopped early (reason given: Insufficient efficacy in planned interim futility analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2012.
- Derived from this study: PubMed 23848826McCallum RW, Lembo A, Esfandyari T, Bhandari BR, Ejskjaer N, Cosentino C, Helton N, Mondou E, Quinn J, Rousseau F; TZP-102 Phase 2b Study Group. Phase 2b, randomized, double-blind 12-week studies of TZP-102, a ghrelin receptor agonist for diabetic gastroparesis. Neurogastroenterol Motil. 2013 Nov;25(11):e705-17. doi: 10.1111/nmo.12184. Epub 2013 Jul 15.
Related trials for Diabetic Gastroparesis
Enrolling by invitationObservational study
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Active, not recruiting
Impact of Per Oral Pyloromyotomy (POP) on Glycemic Control in Diabetes
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Washed Microbiota Transplantation for Diabetic Gastroparesis
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Continuous Glucose Metrics in Patients With Gastroparesis in Type 1 or Type 2 Diabetes
Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
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.
Elsa Mondou, M.D. study director
Tranzyme, Inc.
35 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 10 mg TZP-102 in people with Diabetic Gastroparesis, run by Tranzyme, Inc. at 35 sites in 2 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 7 inclusion and 5 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: stopped early, as of the sponsor's last update on 20 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 35 sites in United States, Poland. 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 was stopped early (reason given: Insufficient efficacy in planned interim futility analysis). Results are not available in the source record.
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 symptoms associated with diabetic gastroparesis (time frame: 12 Weeks). 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 NCT01664637, 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 20 Dec 2012.