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

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ClinicalTrials.gov Identifier: NCT02267525
Recruitment Status : Completed
First Posted : October 17, 2014
Last Update Posted : August 22, 2017
Sponsor:
Collaborator:
Alfasigma S.p.A.
Information provided by (Responsible Party):
Theravance Biopharma R & D, Inc.

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.

Condition or disease Intervention/treatment Phase
Gastroparesis Drug: Velusetrag Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 233 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (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
Actual Study Start Date : December 2014
Primary Completion Date : June 2017
Study Completion Date : June 2017

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 7-day mean GCSI-24H (Gastroparesis Cardinal Symptoms Index) composite score [ Time Frame: At Week 4 ]

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


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02267525


Sponsors and Collaborators
Theravance Biopharma R & D, Inc.
Alfasigma S.p.A.
Investigators
Study Director: Deanna Nguyen, MD Theravance Biopharma

Responsible Party: Theravance Biopharma R & D, Inc.
ClinicalTrials.gov Identifier: NCT02267525     History of Changes
Other Study ID Numbers: 0099
First Posted: October 17, 2014    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
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