Diabetic Gastroparesis Efficacy/Safety Study of TZP-102
NCT ID: NCT01664637
Last Updated: 2012-12-20
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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TERMINATED
PHASE2
120 participants
INTERVENTIONAL
2012-08-31
2013-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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TZP-102 three times a day
10 mg TZP-102 will be taken 30 minutes prior to each main meal for a total of three daily doses.
10 mg TZP-102
One oval-shaped, opaque-white, hard gelatin capsule containing active ingredient will be taken orally three times a day for 12 weeks
Placebo three times a day
Placebo will be taken 30 minutes prior to each main meal for a total of three daily doses.
Placebo
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
Interventions
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10 mg TZP-102
One oval-shaped, opaque-white, hard gelatin capsule containing active ingredient will be taken orally three times a day for 12 weeks
Placebo
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
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
* 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
Exclusion Criteria
* 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
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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Elsa Mondou, M.D.
Role: STUDY_DIRECTOR
Tranzyme, Inc.
Locations
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Tranzyme Investigational Site
Huntsville, Alabama, United States
Tranzyme Investigational Site
Tucson, Arizona, United States
Tranzyme Investigational Site
North Little Rock, Arkansas, United States
Tranzyme Investigational Site
Long Beach, 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
Anderson, Indiana, United States
Tranzyme Investigational Site
Indianapolis, 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
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
El Paso, Texas, United States
Tranzyme Investigational Site
Bialystok, , Poland
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
Lublin, , Poland
Tranzyme Investigational Site
Lublin, , Poland
Tranzyme Investigational Site
Olsztyn, , Poland
Tranzyme Investigational Site
Rzeszów, , Poland
Tranzyme Investigational Site
Warsaw, , Poland
Tranzyme Investigational Site
Zgierz, , Poland
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-G004
Identifier Type: -
Identifier Source: org_study_id