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

Theravance Biopharma

Status and phase: Completed; Phase 2

Conditions: Gastroparesis

Treatments: Drug: Velusetrag; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02267525

0099

Details and patient eligibility

About

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.

Enrollment: 233 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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233 participants in 4 patient groups, including a placebo group

Velusetrag 5mg

Experimental group

Description:

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

Treatment:

Drug: Velusetrag

Velusetrag 15mg

Experimental group

Description:

Velusetrag 15mg capsules QD x 12 weeks

Treatment:

Drug: Velusetrag

Velusetrag 30mg

Experimental group

Description:

Velusetrag 30mg capsules QD x 12 weeks

Treatment:

Drug: Velusetrag

Placebo

Placebo Comparator group

Description:

Placebo capsules QD x 12 weeks

Treatment:

Drug: Placebo