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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

August 10, 2012
December 18, 2012
August 2012
January 2013   (final data collection date for primary outcome measure)
Change from baseline in symptoms associated with diabetic gastroparesis [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01664637 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Diabetic Gastroparesis Efficacy/Safety Study of TZP-102
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetic Gastroparesis
  • 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
  • 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
  • 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.
    Intervention: Drug: 10 mg TZP-102
  • 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.
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
120
February 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Poland
 
NCT01664637
TZP-102-CL-G004
Yes
Tranzyme, Inc.
Tranzyme, Inc.
Not Provided
Study Director: Elsa Mondou, M.D. Tranzyme, Inc.
Tranzyme, Inc.
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP