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

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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
Portland, Oregon 97210
827
mi
from 91732
Portland, OR
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Anderson, Indiana 46016
1819
mi
from 91732
Anderson, IN
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Boston, Massachusetts 02215
2578
mi
from 91732
Boston, MA
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El Paso, Texas 79905
686
mi
from 91732
El Paso, TX
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Fayetteville, North Carolina 28304
2213
mi
from 91732
Fayetteville, NC
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Hialeah, Florida 33016
2315
mi
from 91732
Hialeah, FL
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Huntsville, Alabama 35801
1784
mi
from 91732
Huntsville, AL
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Jonesboro, Arkansas 72401
1546
mi
from 91732
Jonesboro, AR
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Kansas City, Kansas 66160
1339
mi
from 91732
Kansas City, KS
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Long Beach, California 90822
23
mi
from 91732
Long Beach, CA
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Mexico, Missouri 65265
1485
mi
from 91732
Mexico, MO
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Monroe, Louisiana 71201
1495
mi
from 91732
Monroe, LA
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Oklahoma City, Oklahoma 73104
1164
mi
from 91732
Oklahoma City, OK
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Tucson, Arizona 85710
426
mi
from 91732
Tucson, AZ
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