Clinical trial NCT01664637: Diabetic Gastroparesis Efficacy/Safety Study of TZP-102
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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Diabetic Gastroparesis
Keywords: diabetic gastroparesis
delayed gastric emptying
gastroparesis
diabetes mellitus, Type 1
diabetes mellitus, Type 2
Lead sponsor: Tranzyme, Inc.
Sponsor class: INDUSTRY
First posted: 2012-08-14
Enrollment: 120
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 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.


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

Primary outcomes:
measure: Change from baseline in symptoms associated with diabetic gastroparesis
timeFrame: 12 Weeks
Secondary outcomes:
measure: Change from baseline in health-related quality of life
timeFrame: 12 Weeks
measure: Adverse events (AEs), vital signs, ECGs, clinical laboratory parameters
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Tranzyme Investigational Site
state: Alabama
city: Tucson
country: United States
facility: Tranzyme Investigational Site
state: Arizona
city: North Little Rock
country: United States
facility: Tranzyme Investigational Site
state: Arkansas
city: Long Beach
country: United States
facility: Tranzyme Investigational Site
state: California
city: Ventura
country: United States
facility: Tranzyme Investigational Site
state: California
city: Hialeah
country: United States
facility: Tranzyme Investigational Site
state: Florida
city: Inverness
country: United States
facility: Tranzyme Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Tranzyme Investigational Site
state: Florida
city: Miami
country: United States
facility: Tranzyme Investigational Site
state: Florida
city: Miami
country: United States
facility: Tranzyme Investigational Site
state: Florida
city: New Smyrna Beach
country: United States
facility: Tranzyme Investigational Site
state: Florida
city: Anderson
country: United States
facility: Tranzyme Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: Tranzyme Investigational Site
state: Indiana
city: Kansas City
country: United States
facility: Tranzyme Investigational Site
state: Kansas
city: Monroe
country: United States
facility: Tranzyme Investigational Site
state: Louisiana
city: Boston
country: United States
facility: Tranzyme Investigational Site
state: Massachusetts
city: Mexico
country: United States
facility: Tranzyme Investigational Site
state: Missouri
city: Raleigh
country: United States
facility: Tranzyme Investigational Site
state: North Carolina
city: Salisbury
country: United States
facility: Tranzyme Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Tranzyme Investigational Site
state: North Carolina
city: Oklahoma City
country: United States
facility: Tranzyme Investigational Site
state: Oklahoma
city: Portland
country: United States
facility: Tranzyme Investigational Site
state: Oregon
city: El Paso
country: United States
facility: Tranzyme Investigational Site
state: Texas
city: Bialystok
country: Poland
facility: Tranzyme Investigational Site
city: Bialystok
country: Poland
facility: Tranzyme Investigational Site
city: Bydgoszcz
country: Poland
facility: Tranzyme Investigational Site
city: Kielce
country: Poland
facility: Tranzyme Investigational Site
city: Krakow
country: Poland
facility: Tranzyme Investigational Site
city: Lodz
country: Poland
facility: Tranzyme Investigational Site
city: Lublin
country: Poland
facility: Tranzyme Investigational Site
city: Lublin
country: Poland
facility: Tranzyme Investigational Site
city: Olsztyn
country: Poland
facility: Tranzyme Investigational Site
city: Rzeszow
country: Poland
facility: Tranzyme Investigational Site
city: Warsaw
country: Poland
facility: Tranzyme Investigational Site
city: Zgierz
country: Poland
facility: Tranzyme Investigational Site
Study officials:
affiliation: Tranzyme, Inc.
name: Elsa Mondou, M.D.
role: STUDY_DIRECTOR
References:
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.