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

Tranzyme

Status and phase: Terminated; Phase 2

Conditions: Diabetic Gastroparesis

Treatments: Drug: 10 mg TZP-102; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01664637

TZP-102-CL-G004

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

TZP-102 three times a day

Experimental group

Description:

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

Treatment:

Drug: 10 mg TZP-102

Placebo three times a day

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo