Diabetic Gastroparesis Efficacy/Safety Study of TZP-102 (DIGEST)

This study has been terminated.
(Insufficient efficacy in planned interim futility analysis)
Sponsor:
Information provided by (Responsible Party):
Tranzyme, Inc.
ClinicalTrials.gov Identifier:
NCT01664637
First received: August 10, 2012
Last updated: December 18, 2012
Last verified: December 2012
  Purpose

The purpose of this study is to test the safety and effectiveness of 10 mg TZP-102 given prior to meals three times a day compared to placebo (capsule that looks like active study drug but contains no active drug), administered for 12 weeks, in diabetic subjects with symptoms associated with gastroparesis.


Condition Intervention Phase
Diabetic Gastroparesis
Drug: 10 mg 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, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Evaluation of the Efficacy and Safety of TZP-102 Given Orally Three Times a Day for the Treatment of Symptoms Associated With Diabetic Gastroparesis

Resource links provided by NLM:


Further study details as provided by Tranzyme, Inc.:

Primary Outcome Measures:
  • Change from baseline in symptoms associated with diabetic gastroparesis [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in health-related quality of life [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Adverse events (AEs), vital signs, ECGs, clinical laboratory parameters [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: August 2012
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: 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 Comparator: Placebo three times a day
Placebo will be taken 30 minutes prior to each main meal for a total of three daily doses.
Drug: 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

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
  • 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:

  • 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 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
  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: NCT01664637

  Show 35 Study Locations
Sponsors and Collaborators
Tranzyme, Inc.
Investigators
Study Director: Elsa Mondou, M.D. Tranzyme, Inc.
  More Information

No publications provided by Tranzyme, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tranzyme, Inc.
ClinicalTrials.gov Identifier: NCT01664637     History of Changes
Other Study ID Numbers: TZP-102-CL-G004
Study First Received: August 10, 2012
Last Updated: December 18, 2012
Health Authority: United States: Food and Drug Administration
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Tranzyme, Inc.:
diabetic gastroparesis
delayed gastric emptying
gastroparesis
diabetes mellitus, Type 1
diabetes mellitus, Type 2

Additional relevant MeSH terms:
Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 29, 2014