Status:
COMPLETED
The Diabetic and Idiopathic Gastroparesis Efficacy, Safety, and Tolerability (DIGEST) Study
Lead Sponsor:
Theravance Biopharma
Collaborating Sponsors:
Alfasigma S.p.A.
Conditions:
Gastroparesis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Study 0099 explores the efficacy and safety of multiple doses of velusetrag in the treatment of symptoms in subjects with diabetic or idiopathic gastroparesis. Three dose levels of velusetrag will be ...
Eligibility Criteria
Inclusion
- Symptoms of gastroparesis (eg, nausea, early satiety, fullness, bloating, upper abdominal pain, retching or vomiting) for at least 3 months prior to Screening
- Composite score ≥2and \<5 on nausea, bloating, feeling excessively full after meals, and not able to finish a normal-sized meal items (on the GCSI-2W) at Screening
- Delayed gastric emptying by either GES (gastric emptying scintigraphy) or GEBT(gastric emptying breath test)
- Upper gastrointestinal obstruction ruled out by endoscopy or other imaging (eg, computed tomography) after the onset of gastroparesis symptoms
- Willing to abstain from prohibited medications, including but not limited to, anticholinergics, acetylcholinesterase antagonists, or promotility medications (eg, metoclopramide, domperidone, prucalopride, erythromycin) for: 24 hours prior to gastric emptying test during Screening, if applicable; 24 hours prior to start of the Baseline period; and during the Baseline Period
- GCSI-24H 7-day mean composite score ≥2.5 and \<5 at Day 1
Exclusion
- If Type 1 or Type 2 diabetic, a glycosylated hemoglobin (HbA1c) level \>11%
- Prior history of gastric surgery, including but not limited to gastrectomy, gastric bypass, gastric banding, pyloroplasty, vagotomy, or fundoplication, which has manipulated the natural anatomy of the stomach
- History of intrapyloric botulinum toxin injection within 3 months of Screening or currently has functioning implantable electric stimulator
- History of alcohol or drug abuse or dependence within the last year prior to Screening
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
233 Patients enrolled
Trial Details
Trial ID
NCT02267525
Start Date
December 1 2014
End Date
June 1 2017
Last Update
April 17 2018
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