Diabetic Gastroparesis Efficacy/Safety Study of TZP-102
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | August 2012 |
| End Date: | April 2013 |
| Contact: | Beth Chamblin, B.S. |
| Email: | BChamblin@tranzyme.com |
| Phone: | 919-328-1132 |
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.
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
We found this trial at
14
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials