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GastroparesisPhase 2NCT01452815

Affects of Once-daily Oral Administration of TZP-102 on the Treatment of Symptoms Associated With Diabetic Gastroparesis

A Phase 2 study testing 10mg TZP-102 and 20mg TZP-102 in people with Gastroparesis and Diabetes Mellitus, Type 1, run by Tranzyme, Inc. at 52 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to test the safety and effectiveness of two dosage levels (10mg and 20mg) of TZP-102 compared to placebo (capsule that looks like the study drug but contains no active drug), administered once-daily 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
What is being tested?
10mg TZP-102 and 20mg TZP-102
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
201 participants
Where
52 sitesin 8 countries
Study dates
Sep 2011to Nov 2012
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
  • Gastric half-emptying time >82 minutes, demonstrated by the Gastric Emptying Breath Test performed at the Screening Visit OR documented delayed gastric emptying within the previous 24 months
  • Mild to moderate severity of gastroparesis symptoms during the screening period
  • Body Mass Index (BMI) < 45.0 at the Screening Visit
Show all 10Show fewer
  • Glycosylated hemoglobin (HbA1c) level < 11.0% at the Screening Visit
  • Upper gastrointestinal obstruction ruled out by endoscopy or barium scan
  • Concomitant medications must be stable for at least 2 weeks leading up to the Baseline 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

  • Persistent daily vomiting
  • 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 within 2 weeks prior to the Screening Visit
  • Required in-patient hospitalization for treatment of gastroparesis within 2 weeks prior to the Screening Visit
  • Required parenteral nutrition for treatment of gastroparesis within 2 months prior to the Screening Visit
Show all 30Show fewer
  • Active gastric pacemaker within 3 months prior to the Screening Visit
  • Participated in an investigational study within 30 days prior to the Screening Visit
  • Chronic severe diarrhea
  • Diabetic ketoacidosis that required inpatient hospitalization within 30 days prior to the Screening Visit
  • History of any eating disorder within 2 years prior to the Screening Visit
  • Chronic obstructive pulmonary disease (COPD) or chronic asthma
  • Chronic smoker that is unable or unwilling to abstain from smoking during the two visits that the gastric emptying breath test will be performed
  • History of risk factors for Torsades de Pointes
  • Corrected QT interval calculated using Fredericia's formula >= 500 msec, recorded and confirmed on any of the three ECG assessments performed during the screening period
  • Bradycardia or hypotension assessed as clinically-significant by the investigator
  • Requires treatment with concomitant medication that is a substrate of Cytochrome P450 isoenzyme 3A4 and known to have a clinically recognized risk for Torsades de Pointes
  • History of acute myocardial infarction, unstable angina or a transient (cerebral) ischemic attack within 12 months prior to the Screening Visit
  • History of severe depression, psychiatric disorder or cognitive impairment
  • History of alcohol or drug abuse or dependency within 2 years prior to the Screening Visit
  • Taking opiates for abdominal pain
  • Known history of Hepatitis B or C or HIV infection
  • Requires dialysis or elevated creatinine at the Screening Visit
  • Abnormal liver function tests at the Screening Visit
  • Uncontrolled hypo- or hyperthyroidism
  • Adrenal insufficiency
  • Active malignancy other than basal cell or squamous cell carcinoma of the skin
  • Pregnant or breast-feeding
  • Allergies to components of the breath test meal or severe lactose intolerance
  • 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

52 sites in 8 countries.

52 sites in 8 countries

United States31 sites

  • Tranzyme Investigational Site

    Anderson, Indiana, 46016

  • Tranzyme Investigational Site

    Boston, Massachusetts, 02215

  • Tranzyme Investigational Site

    El Paso, Texas, 79905

  • Tranzyme Investigational Site

    Fayetteville, North Carolina, 28304

  • Tranzyme Investigational Site

    Hialeah, Florida, 33016

  • Tranzyme Investigational Site

    Houston, Texas, 77034

  • Tranzyme Investigational Site

    Huntsville, Alabama, 35801

  • Tranzyme Investigational Site

    Inverness, Florida, 34450

  • Tranzyme Investigational Site

    Jackson, Tennessee, 38305

  • Tranzyme Investigational Site

    Jacksonville, Florida, 32256

  • Tranzyme Investigational Site

    Jonesboro, Arkansas, 72401

  • Tranzyme Investigational Site

    Kansas City, Kansas, 66160

  • Tranzyme Investigational Site

    Little Rock, Arkansas, 72117

  • 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

    Oak Lawn, Illinois, 60453

  • Tranzyme Investigational Site

    Oklahoma City, Oklahoma, 73104

  • Tranzyme Investigational Site

    Philadelphia, Pennsylvania, 19140

  • Tranzyme Investigational Site

    Port Orange, Florida, 32127

  • Tranzyme Investigational Site

    Portland, Oregon, 97210

  • Tranzyme Investigational Site

    Raleigh, North Carolina, 27612

  • Tranzyme Investigational Site

    Salisbury, North Carolina, 28144

  • Tranzyme Investigational Site

    Stanford, California, 94305

  • Tranzyme Investigational Site

    Tacoma, Washington, 98405

  • Tranzyme Investigational Site

    Tucson, Arizona, 85710

  • Tranzyme Investigational Site

    Ventura, California, 93003

  • Tranzyme Investigational Site

    Winston-Salem, North Carolina, 27103

Other trials in United States

Poland7 sites

  • Tranzyme Investigational Site

    Bialystok

  • Tranzyme Investigational Site

    Bydgoszcz, 85-094

  • Tranzyme Investigational Site

    Kielce, 25-035

  • Tranzyme Investigational Site

    Krakow

  • Tranzyme Investigational Site

    Lodz

  • Tranzyme Investigational Site

    Olsztyn

  • Tranzyme Investigational Site

    Warsaw, 02-097

Other trials in Poland

Belgium3 sites

  • Tranzyme Investigational Site

    Bruges, 8310

  • Tranzyme Investigational Site

    Brussels, 1200

  • Tranzyme Investigational Site

    Ghent, B-9000

Other trials in Belgium

Denmark3 sites

  • Tranzyme Investigational Site

    Aarhus, 8000

  • Tranzyme Investigational Site

    Gentofte Municipality

  • Tranzyme Investigational Site

    Odense, 5000

Other trials in Denmark

Germany3 sites

  • Tranzyme Investigational Site

    Essen, 45136

  • Tranzyme Investigational Site

    Mainz, 55116

  • Tranzyme Investigational Site

    Stuttgart, 70191

Other trials in Germany

Finland2 sites

  • Tranzyme Investigational Site

    Porvoo, 06151

  • Tranzyme Investigational Site

    Tampere

Other trials in Finland

Sweden2 sites

  • Tranzyme Investigational Site

    Stockholm

  • Tranzyme Investigational Site

    Uppsala

Other trials in Sweden

Norway1 site

  • Tranzyme Investigational Site

    Bergen, 5021

Other trials in Norway

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Evaluation of the Efficacy and Safety of Once-Daily Administrations of TZP-102 for the Treatment of Symptoms Associated With Diabetic Gastroparesis

The purpose of this study is to test the safety and effectiveness of two dosage levels (10mg and 20mg) of TZP-102 compared to placebo (capsule that looks like the study drug but contains no active drug), administered once-daily for 12 weeks, in diabetic subjects with symptoms associated with gastroparesis.

Read the detailed description

Considered subjects will be screened to determine eligibility for entry into the study. The Screening Visit must take place at least 14 days, but not more than 21 days, before the planned date of study entry (randomization and administration of the first dose of study drug on Study Day 1). The baseline evaluation of gastric emptying must be scheduled at least 7 days (in the U.S.) and 10 days (in Europe) before the Day 1 Visit. Subjects will answer questions relating to their gastroparesis symptoms in an electronic diary (like a palm pilot) beginning on the first day of the screening period.

Eligible subjects will be randomized to receive placebo or one of two dosages of TZP-102 (10mg or 20mg) once daily for 12 weeks. After randomization and administration of the first dose of study drug on Study Day 1 (the Study Entry Visit), subsequent visits to the clinic will be scheduled every two weeks during the 12-week Treatment period and 4-week Follow-Up Period.

All visits will be conducted on an outpatient basis. Visits for a given subject throughout the study should be scheduled to start at approximately the same time, in the morning. Subjects will be instructed to take their daily dose of study drug each morning (when not attending a study visit), at least 30 minutes before breakfast. Subjects will be instructed to not take study drug on the morning of each treatment period visit and to bring study drug supplies with them to the clinic; study drug will be administered in the clinic after all scheduled assessments/procedures (after all pre-dose assessments at each of the Day 1 and Week 12 Visits) are completed.

Being tested
Placebo, 10mg TZP-102, 20mg TZP-102
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.

  • PlaceboDrug

    Two #2 oval shaped,opaque-white, hard gelatin shell capsules containing inactive ingredients taken orally once daily for 12 weeks.

  • 10mg TZP-102Drug

    One 10mg #2 oval shaped, opaque-white, hard gelatin shell capsule containing active ingredients and one placebo capsule each taken orally once daily for 12 Weeks

  • 20mg TZP-102Drug

    Two 10mg #2 oval shaped, opaque-white, hard gelatin shell capsules containing active ingredients

Study groups in NCT01452815
Study groupRoleWhat they receive
1Placebo comparatorDrug: placebo
Receives: Drug: Placebo
2Experimental10mg TZP-102
Receives: Drug: 10mg TZP-102
3Experimental20mg TZP-102
Receives: Drug: 20mg TZP-102

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in symptoms associated with diabetic gastroparesis

    Measured: 12 Weeks

Secondary outcomes (4)

  1. Change from baseline on health-related quality of life

    Measured: 12 Weeks

  2. Adverse Events (AEs)

    Measured: 12 Weeks

  3. Cardiovascular Parameters (blood pressure, heart rate, 12-Lead ECG)

    Measured: 12 Weeks

  4. Clinical Chemistry and Hematology 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.

  1. First posted17 Oct 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionNov 2012
  4. Study completionNov 2012

Resources

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
201 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01452815
Sponsor's protocol ID
TZP-102-CL-G003
Status last verified
Aug 2012
First submitted
12 Oct 2011
Last updated
25 Apr 2013
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 10mg TZP-102 and 20mg TZP-102 in people with Gastroparesis and Diabetes Mellitus, Type 1, run by Tranzyme, Inc. at 52 sites in 8 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 30 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 25 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in United States, Poland, Belgium, Denmark, Germany and 3 more countries. 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 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 NCT01452815, 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 25 Apr 2013.

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