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
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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 |
Actual Primary Completion Date : | June 2017 |
Actual Study Completion Date : | June 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Velusetrag 5mg
Velusetrag 5mg capsules QD (once daily) x 12 weeks
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Drug: Velusetrag
Other Name: TD-5108 |
Experimental: Velusetrag 15mg
Velusetrag 15mg capsules QD x 12 weeks
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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 |
- 7-day mean GCSI-24H (Gastroparesis Cardinal Symptoms Index) composite score [ Time Frame: At Week 4 ]
- Gastric emptying half-time [ Time Frame: At Week 4 ]
- Adverse events [ Time Frame: 103 days ]

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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 |
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

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
Study Director: | Deanna Nguyen, MD | Theravance Biopharma |
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 |
Gastroparesis Diabetic Idiopathic |
Gastroparesis Stomach Diseases Gastrointestinal Diseases |
Digestive System Diseases Paralysis Neurologic Manifestations |