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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Alfa Wassermann S.p.A.
Information provided by (Responsible Party):
Theravance Biopharma R & D, Inc.
ClinicalTrials.gov Identifier:
NCT02267525
First received: October 14, 2014
Last updated: March 14, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention Phase
Gastroparesis
Drug: Velusetrag
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Treatment
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

Further study details as provided by Theravance Biopharma R & D, Inc.:

Primary Outcome Measures:
  • 7-day mean GCSI-24H (Gastroparesis Cardinal Symptoms Index) composite score [ Time Frame: At Week 4 ]

Secondary Outcome Measures:
  • Gastric emptying half-time [ Time Frame: At Week 4 ]
  • Adverse events [ Time Frame: 103 days ]

Enrollment: 233
Study Start Date: December 2014
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Velusetrag 5mg
Velusetrag 5mg capsules QD (once daily) x 12 weeks
Drug: Velusetrag
Other Name: TD-5108
Experimental: Velusetrag 15mg
Velusetrag 15mg capsules QD x 12 weeks
Drug: Velusetrag
Other Name: TD-5108
Experimental: Velusetrag 30mg
Velusetrag 30mg capsules QD x 12 weeks
Drug: Velusetrag
Other Name: TD-5108
Placebo Comparator: Placebo
Placebo capsules QD x 12 weeks
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02267525

Locations
United States, Tennessee
Clinsearch, LLC
Chattanooga, Tennessee, United States, 37421
Sponsors and Collaborators
Theravance Biopharma R & D, Inc.
Alfa Wassermann S.p.A.
Investigators
Study Director: Dan Canafax, PharmD, FCCP Theravance Biopharma
  More Information

Responsible Party: Theravance Biopharma R & D, Inc.
ClinicalTrials.gov Identifier: NCT02267525     History of Changes
Other Study ID Numbers: 0099
Study First Received: October 14, 2014
Last Updated: March 14, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Theravance Biopharma R & D, Inc.:
Gastroparesis
Diabetic
Idiopathic

Additional relevant MeSH terms:
Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on March 30, 2017