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

Gastroparesis Clinical Trial

— DIGEST  

Official title:

A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy, Safety, and Tolerability of Velusetrag for the Treatment of Diabetic or Idiopathic Gastroparesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02267525
• Other study ID #: 0099
• Status: Completed
• Phase: Phase 2
• First received: October 14, 2014
• Last updated: April 13, 2018
• Start date: December 2014
• Est. completion date: June 2017

Study information

• Verified date: April 2018
• Source: Theravance Biopharma R & D, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 233
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastroparesis

Intervention

Drug:
• Velusetrag

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Theravance Biopharma R & D, Inc.	Alfasigma S.p.A.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	7-day mean GCSI-24H (Gastroparesis Cardinal Symptoms Index) composite score		At Week 4
Secondary	Gastric emptying half-time		At Week 4
Secondary	Adverse events		103 days