Affects of Once-daily Oral Administration of TZP-102 on the Treatment of Symptoms Associated With Diabetic Gastroparesis
NCT ID: NCT01452815
Last Updated: 2013-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
201 participants
INTERVENTIONAL
2011-09-30
2012-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Drug: placebo
Placebo
Two #2 oval shaped,opaque-white, hard gelatin shell capsules containing inactive ingredients taken orally once daily for 12 weeks.
2
10mg TZP-102
10mg TZP-102
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
3
20mg TZP-102
20mg TZP-102
Two 10mg #2 oval shaped, opaque-white, hard gelatin shell capsules containing active ingredients
Interventions
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Placebo
Two #2 oval shaped,opaque-white, hard gelatin shell capsules containing inactive ingredients taken orally once daily for 12 weeks.
10mg TZP-102
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-102
Two 10mg #2 oval shaped, opaque-white, hard gelatin shell capsules containing active ingredients
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
Exclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Tranzyme, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Connie Cosentino
Role: STUDY_DIRECTOR
Tranzyme Pharma
Locations
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Tranzyme Investigational Site
Huntsville, Alabama, United States
Tranzyme Investigational Site
Tucson, Arizona, United States
Tranzyme Investigational Site
Jonesboro, Arkansas, United States
Tranzyme Investigational Site
Little Rock, Arkansas, United States
Tranzyme Investigational Site
Long Beach, California, United States
Tranzyme Investigational Site
Stanford, California, United States
Tranzyme Investigational Site
Ventura, California, United States
Tranzyme Investigational Site
Hialeah, Florida, United States
Tranzyme Investigational Site
Inverness, Florida, United States
Tranzyme Investigational Site
Jacksonville, Florida, United States
Tranzyme Investigational Site
Miami, Florida, United States
Tranzyme Investigational Site
Miami, Florida, United States
Tranzyme Investigational Site
New Smyrna Beach, Florida, United States
Tranzyme Investigational Site
Port Orange, Florida, United States
Tranzyme Investigational Site
Oak Lawn, Illinois, United States
Tranzyme Investigational Site
Anderson, Indiana, United States
Tranzyme Investigational Site
Kansas City, Kansas, United States
Tranzyme Investigational Site
Monroe, Louisiana, United States
Tranzyme Investigational Site
Boston, Massachusetts, United States
Tranzyme Investigational Site
Mexico, Missouri, United States
Tranzyme Investigational Site
Fayetteville, North Carolina, United States
Tranzyme Investigational Site
Raleigh, North Carolina, United States
Tranzyme Investigational Site
Salisbury, North Carolina, United States
Tranzyme Investigational Site
Winston-Salem, North Carolina, United States
Tranzyme Investigational Site
Oklahoma City, Oklahoma, United States
Tranzyme Investigational Site
Portland, Oregon, United States
Tranzyme Investigational Site
Philadelphia, Pennsylvania, United States
Tranzyme Investigational Site
Jackson, Tennessee, United States
Tranzyme Investigational Site
El Paso, Texas, United States
Tranzyme Investigational Site
Houston, Texas, United States
Tranzyme Investigational Site
Tacoma, Washington, United States
Tranzyme Investigational Site
Bruges, , Belgium
Tranzyme Investigational Site
Brussels, , Belgium
Tranzyme Investigational Site
Ghent, , Belgium
Tranzyme Investigational Site
Aarhus, , Denmark
Tranzyme Investigational Site
Gentofte Municipality, , Denmark
Tranzyme Investigational Site
Odense, , Denmark
Tranzyme Investigational Site
Porvoo, , Finland
Tranzyme Investigational Site
Tampere, , Finland
Tranzyme Investigational Site
Essen, , Germany
Tranzyme Investigational Site
Mainz, , Germany
Tranzyme Investigational Site
Stuttgart, , Germany
Tranzyme Investigational Site
Bergen, , Norway
Tranzyme Investigational Site
Bialystok, , Poland
Tranzyme Investigational Site
Bydgoszcz, , Poland
Tranzyme Investigational Site
Kielce, , Poland
Tranzyme Investigational Site
Krakow, , Poland
Tranzyme Investigational Site
Lodz, , Poland
Tranzyme Investigational Site
Olsztyn, , Poland
Tranzyme Investigational Site
Warsaw, , Poland
Tranzyme Investigational Site
Stockholm, , Sweden
Tranzyme Investigational Site
Uppsala, , Sweden
Countries
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References
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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.
Other Identifiers
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TZP-102-CL-G003
Identifier Type: -
Identifier Source: org_study_id
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