Clinical trial NCT00889486: Safety and Efficacy of Once-daily Oral Administrations of TZP-102 for Gastroparesis in Patients With Diabetes Mellitus
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastroparesis
Diabetes Mellitus
Keywords: gastroparesis
diabetes mellitus
delayed gastric emptying
Lead sponsor: Tranzyme, Inc.
Sponsor class: INDUSTRY
First posted: 2009-04-29
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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.
* 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.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: change from baseline in gastric half-emptying time
timeFrame: study days 1 and 28
Secondary outcomes:
measure: change from baseline in gastroparesis symptoms and health-related quality of life
timeFrame: study days 8, 15 and 28
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Long Beach VA Medical Center
state: California
city: Los Angeles
country: United States
facility: Impact Clinical Trials
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center Research Institute
state: California
city: Tampa
country: United States
facility: University of South Florida/Tampa General Hospital
state: Florida
city: Anderson
country: United States
facility: Saint John's Research Institute
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Louisville
country: United States
facility: Univ. of Louisville Medical-Dental Complex
state: Kentucky
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: El Paso
country: United States
facility: Texas Tech Univ. Health Sciences Center Dept. of Medicine
state: Texas
city: Aalborg
country: Denmark
facility: Aalborg Hospital
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Gentofte
country: Denmark
facility: Steno Diabetes Center
city: Odense
country: Denmark
facility: Odense University Hospital
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Bialystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Bialymstoku
city: Lodz
country: Poland
facility: Oddzial Kliniczny Diabetologii Samodzielny Publiczny Zaklad
city: Warsaw
country: Poland
facility: Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Ipswich
country: United Kingdom
facility: Ipswich Hospital NHS Trust
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
city: Manchester
country: United Kingdom
facility: Wellcome Truest Clinical Research Facility
Study officials:
References: