Safety and Efficacy of Once-daily Oral Administrations of TZP-102 for Gastroparesis in Patients With Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tranzyme, Inc.
ClinicalTrials.gov Identifier:
NCT00889486
First received: April 28, 2009
Last updated: December 7, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Gastroparesis
Diabetes Mellitus
Drug: TZP-102
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Tranzyme, Inc.:

Primary Outcome Measures:
  • change from baseline in gastric half-emptying time [ Time Frame: study days 1 and 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change from baseline in gastroparesis symptoms and health-related quality of life [ Time Frame: study days 8, 15 and 28 ] [ Designated as safety issue: No ]

Enrollment: 92
Study Start Date: April 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Four placebo capsules taken orally once per day for 28 days
Drug: Placebo
Experimental: 10 mg TZP-102
One 10 mg TZP-102 Capsule and three placebo capsules taken orally once per day for 28 days
Drug: TZP-102 Drug: Placebo
Experimental: 20 mg TZP-102
Two 10 mg TZP-102 Capsules and two placebo capsules taken orally once per day for 28 days
Drug: TZP-102 Drug: Placebo
Experimental: 40 mg TZP-102
Four 10 mg TZP-102 Capsules taken orally once per day for 28 days
Drug: TZP-102

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00889486

  Show 23 Study Locations
Sponsors and Collaborators
Tranzyme, Inc.
  More Information

No publications provided

Responsible Party: Tranzyme, Inc.
ClinicalTrials.gov Identifier: NCT00889486     History of Changes
Other Study ID Numbers: TZP-102-CL-G002
Study First Received: April 28, 2009
Last Updated: December 7, 2012
Health Authority: United States: Food and Drug Administration
Denmark: Danish Medicines Agency
Sweden: Medical Products Agency
Norway: Norwegian Medicines Agency
Poland: The Central Register of Clinical Trials
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Tranzyme, Inc.:
gastroparesis
diabetes mellitus
delayed gastric emptying

Additional relevant MeSH terms:
Diabetes Mellitus
Gastroparesis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014