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

Primary Purpose

Gastroparesis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Velusetrag
Placebo
Sponsored by
Theravance Biopharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroparesis focused on measuring Gastroparesis, Diabetic, Idiopathic

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Velusetrag 5mg

    Velusetrag 15mg

    Velusetrag 30mg

    Placebo

    Arm Description

    Velusetrag 5mg capsules QD (once daily) x 12 weeks

    Velusetrag 15mg capsules QD x 12 weeks

    Velusetrag 30mg capsules QD x 12 weeks

    Placebo capsules QD x 12 weeks

    Outcomes

    Primary Outcome Measures

    7-day mean GCSI-24H (Gastroparesis Cardinal Symptoms Index) composite score

    Secondary Outcome Measures

    Gastric emptying half-time
    Adverse events

    Full Information

    First Posted
    October 14, 2014
    Last Updated
    April 13, 2018
    Sponsor
    Theravance Biopharma
    Collaborators
    Alfasigma S.p.A.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02267525
    Brief Title
    The Diabetic and Idiopathic Gastroparesis Efficacy, Safety, and Tolerability (DIGEST) Study
    Acronym
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2014 (Actual)
    Primary Completion Date
    June 2017 (Actual)
    Study Completion Date
    June 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Theravance Biopharma
    Collaborators
    Alfasigma S.p.A.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastroparesis
    Keywords
    Gastroparesis, Diabetic, Idiopathic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    233 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Velusetrag 5mg
    Arm Type
    Experimental
    Arm Description
    Velusetrag 5mg capsules QD (once daily) x 12 weeks
    Arm Title
    Velusetrag 15mg
    Arm Type
    Experimental
    Arm Description
    Velusetrag 15mg capsules QD x 12 weeks
    Arm Title
    Velusetrag 30mg
    Arm Type
    Experimental
    Arm Description
    Velusetrag 30mg capsules QD x 12 weeks
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo capsules QD x 12 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Velusetrag
    Other Intervention Name(s)
    TD-5108
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    7-day mean GCSI-24H (Gastroparesis Cardinal Symptoms Index) composite score
    Time Frame
    At Week 4
    Secondary Outcome Measure Information:
    Title
    Gastric emptying half-time
    Time Frame
    At Week 4
    Title
    Adverse events
    Time Frame
    103 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Deanna Nguyen, MD
    Organizational Affiliation
    Theravance Biopharma
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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