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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 : April 17, 2018
Sponsor:
Collaborator:
Alfasigma S.p.A.
Information provided by (Responsible Party):
Theravance Biopharma

Study Description
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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 Design
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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
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

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Arms and Interventions
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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


Outcome Measures
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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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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
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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
Alfasigma S.p.A.
Investigators
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Study Director: Deanna Nguyen, MD Theravance Biopharma
More Information
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Responsible Party: Theravance Biopharma
ClinicalTrials.gov Identifier: NCT02267525    
Other Study ID Numbers: 0099
First Posted: October 17, 2014    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Keywords provided by Theravance Biopharma:
Gastroparesis
Diabetic
Idiopathic
Additional relevant MeSH terms:
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Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Paralysis
Neurologic Manifestations