Affects of Once-daily Oral Administration of TZP-102 on the Treatment of Symptoms Associated With Diabetic Gastroparesis
Condition: Gastroparesis; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
MeSH terms: Gastroparesis; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test the safety and effectiveness of two dosage levels (10mg
      and 20mg) of TZP-102 compared to placebo (capsule that looks like the study drug but contains
      no active drug), administered once-daily for 12 weeks, in diabetic subjects with symptoms
      associated with gastroparesis.
    

Detailed description: 
      Considered subjects will be screened to determine eligibility for entry into the study. The
      Screening Visit must take place at least 14 days, but not more than 21 days, before the
      planned date of study entry (randomization and administration of the first dose of study drug
      on Study Day 1). The baseline evaluation of gastric emptying must be scheduled at least 7
      days (in the U.S.) and 10 days (in Europe) before the Day 1 Visit. Subjects will answer
      questions relating to their gastroparesis symptoms in an electronic diary (like a palm pilot)
      beginning on the first day of the screening period.

      Eligible subjects will be randomized to receive placebo or one of two dosages of TZP-102
      (10mg or 20mg) once daily for 12 weeks. After randomization and administration of the first
      dose of study drug on Study Day 1 (the Study Entry Visit), subsequent visits to the clinic
      will be scheduled every two weeks during the 12-week Treatment period and 4-week Follow-Up
      Period.

      All visits will be conducted on an outpatient basis. Visits for a given subject throughout
      the study should be scheduled to start at approximately the same time, in the morning.
      Subjects will be instructed to take their daily dose of study drug each morning (when not
      attending a study visit), at least 30 minutes before breakfast. Subjects will be instructed
      to not take study drug on the morning of each treatment period visit and to bring study drug
      supplies with them to the clinic; study drug will be administered in the clinic after all
      scheduled assessments/procedures (after all pre-dose assessments at each of the Day 1 and
      Week 12 Visits) are completed.
    

Intervention name(s): Placebo; 10mg TZP-102; 20mg TZP-102
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Two #2 oval shaped,opaque-white, hard gelatin shell capsules containing inactive ingredients taken orally once daily for 12 weeks.; One 10mg #2 oval shaped, opaque-white, hard gelatin shell capsule containing active ingredients and one placebo capsule each taken orally once daily for 12 Weeks; Two 10mg #2 oval shaped, opaque-white, hard gelatin shell capsules containing active ingredients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: diabetic gastroparesis; delayed gastric emptying; gastroparesis; diabetes mellitus, Type 1; diabetes mellitus, Type 2