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

Primary Purpose

Diabetic Gastroparesis

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
10 mg TZP-102
Placebo
Sponsored by
Tranzyme, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Gastroparesis focused on measuring diabetic gastroparesis, delayed gastric emptying, gastroparesis, diabetes mellitus, Type 1, diabetes mellitus, Type 2

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tranzyme Investigational Site
  • Tranzyme Investigational Site
  • Tranzyme Investigational Site
  • Tranzyme Investigational Site
  • Tranzyme Investigational Site
  • Tranzyme Investigational Site
  • Tranzyme Investigational Site
  • Tranzyme Investigational Site
  • Tranzyme Investigational Site
  • Tranzyme Investigational Site
  • Tranzyme Investigational Site
  • Tranzyme Investigational Site
  • Tranzyme Investigational Site
  • Tranzyme Investigational Site
  • Tranzyme Investigational Site
  • Tranzyme Investigational Site
  • Tranzyme Investigational Site
  • Tranzyme Investigational Site
  • Tranzyme Investigational Site
  • Tranzyme Investigational Site
  • Tranzyme Investigational Site
  • Tranzyme Investigational Site
  • Tranzyme Investigational Site
  • Tranzyme Investigational Site
  • Tranzyme Investigational Site
  • Tranzyme Investigational Site
  • Tranzyme Investigational Site
  • Tranzyme Investigational Site
  • Tranzyme Investigational Site
  • Tranzyme Investigational Site
  • Tranzyme Investigational Site
  • Tranzyme Investigational Site
  • Tranzyme Investigational Site
  • Tranzyme Investigational Site
  • Tranzyme Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TZP-102 three times a day

Placebo three times a day

Arm Description

10 mg TZP-102 will be taken 30 minutes prior to each main meal for a total of three daily doses.

Placebo will be taken 30 minutes prior to each main meal for a total of three daily doses.

Outcomes

Primary Outcome Measures

Change from baseline in symptoms associated with diabetic gastroparesis

Secondary Outcome Measures

Change from baseline in health-related quality of life
Adverse events (AEs), vital signs, ECGs, clinical laboratory parameters

Full Information

First Posted
August 10, 2012
Last Updated
December 18, 2012
Sponsor
Tranzyme, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01664637
Brief Title
Diabetic Gastroparesis Efficacy/Safety Study of TZP-102
Acronym
DIGEST
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Terminated
Why Stopped
Insufficient efficacy in planned interim futility analysis
Study Start Date
August 2012 (undefined)
Primary Completion Date
January 2013 (Anticipated)
Study Completion Date
February 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tranzyme, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Gastroparesis
Keywords
diabetic gastroparesis, delayed gastric emptying, gastroparesis, diabetes mellitus, Type 1, diabetes mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TZP-102 three times a day
Arm Type
Experimental
Arm Description
10 mg TZP-102 will be taken 30 minutes prior to each main meal for a total of three daily doses.
Arm Title
Placebo three times a day
Arm Type
Placebo Comparator
Arm Description
Placebo will be taken 30 minutes prior to each main meal for a total of three daily doses.
Intervention Type
Drug
Intervention Name(s)
10 mg TZP-102
Intervention Description
One oval-shaped, opaque-white, hard gelatin capsule containing active ingredient will be taken orally three times a day for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Change from baseline in symptoms associated with diabetic gastroparesis
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
Change from baseline in health-related quality of life
Time Frame
12 Weeks
Title
Adverse events (AEs), vital signs, ECGs, clinical laboratory parameters
Time Frame
12 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elsa Mondou, M.D.
Organizational Affiliation
Tranzyme, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Tranzyme Investigational Site
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Tranzyme Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Tranzyme Investigational Site
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Facility Name
Tranzyme Investigational Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
Tranzyme Investigational Site
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Tranzyme Investigational Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Tranzyme Investigational Site
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452
Country
United States
Facility Name
Tranzyme Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Tranzyme Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Tranzyme Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33183
Country
United States
Facility Name
Tranzyme Investigational Site
City
New Smyrna Beach
State/Province
Florida
ZIP/Postal Code
32168
Country
United States
Facility Name
Tranzyme Investigational Site
City
Anderson
State/Province
Indiana
ZIP/Postal Code
46106
Country
United States
Facility Name
Tranzyme Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Tranzyme Investigational Site
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Tranzyme Investigational Site
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States
Facility Name
Tranzyme Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Tranzyme Investigational Site
City
Mexico
State/Province
Missouri
ZIP/Postal Code
65265
Country
United States
Facility Name
Tranzyme Investigational Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Tranzyme Investigational Site
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Tranzyme Investigational Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Tranzyme Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Tranzyme Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Tranzyme Investigational Site
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
Facility Name
Tranzyme Investigational Site
City
Bialystok
ZIP/Postal Code
15732
Country
Poland
Facility Name
Tranzyme Investigational Site
City
Bialystok
ZIP/Postal Code
15950
Country
Poland
Facility Name
Tranzyme Investigational Site
City
Bydgoszcz
ZIP/Postal Code
85094
Country
Poland
Facility Name
Tranzyme Investigational Site
City
Kielce
ZIP/Postal Code
25035
Country
Poland
Facility Name
Tranzyme Investigational Site
City
Krakow
ZIP/Postal Code
31530
Country
Poland
Facility Name
Tranzyme Investigational Site
City
Lodz
ZIP/Postal Code
90251
Country
Poland
Facility Name
Tranzyme Investigational Site
City
Lublin
ZIP/Postal Code
20090
Country
Poland
Facility Name
Tranzyme Investigational Site
City
Lublin
ZIP/Postal Code
20607
Country
Poland
Facility Name
Tranzyme Investigational Site
City
Olsztyn
ZIP/Postal Code
10561
Country
Poland
Facility Name
Tranzyme Investigational Site
City
Rzeszow
ZIP/Postal Code
35073
Country
Poland
Facility Name
Tranzyme Investigational Site
City
Warsaw
ZIP/Postal Code
02097
Country
Poland
Facility Name
Tranzyme Investigational Site
City
Zgierz
ZIP/Postal Code
95100
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
23848826
Citation
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.
Results Reference
derived

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Diabetic Gastroparesis Efficacy/Safety Study of TZP-102

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