The Diabetic and Idiopathic Gastroparesis Efficacy, Safety, and Tolerability (DIGEST) Study

Phase 2

Completed

• Conditions: Gastroparesis
• Interventions: Drug: Placebo; Drug: Velusetrag

• Registration Number: NCT02267525
• Lead Sponsor: Theravance Biopharma

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 evaluated and compared to placebo for approximately 12 weeks of therapy. In addition, the study will be used to evaluate the psychometric properties of the Gastroparesis Rating Scale (GRS), a daily patient-reported outcome (PRO) measure.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-14
• Study First Submitted QC: 2014-10-14
• Study First Posted: 2014-10-17
• Study Start: 2014-12
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2018-04
• Disposition First Submitted: 2018-04-13
• Disposition First Submitted QC: 2018-04-13
• Last Update Submitted: 2018-04-13
• Disposition First Posted: 2018-04-17
• Last Update Posted: 2018-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 233

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo capsules QD x 12 weeks
Velusetrag 30mg	Velusetrag	Velusetrag 30mg capsules QD x 12 weeks
Velusetrag 5mg	Velusetrag	Velusetrag 5mg capsules QD (once daily) x 12 weeks
Velusetrag 15mg	Velusetrag	Velusetrag 15mg capsules QD x 12 weeks

Primary Outcome Measures

Name	Time	Method
7-day mean GCSI-24H (Gastroparesis Cardinal Symptoms Index) composite score	At Week 4

Secondary Outcome Measures

Name	Time	Method
Gastric emptying half-time	At Week 4
Adverse events	103 days