Clinical trial NCT02267525: The Diabetic and Idiopathic Gastroparesis Efficacy, Safety, and Tolerability (DIGEST) Study
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastroparesis
Keywords: Gastroparesis
Diabetic
Idiopathic
Lead sponsor: Theravance Biopharma
Sponsor class: INDUSTRY
Collaborators: name: Alfasigma S.p.A.
First posted: 2014-10-17
Enrollment: 233
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 7-day mean GCSI-24H (Gastroparesis Cardinal Symptoms Index) composite score
timeFrame: At Week 4
Secondary outcomes:
measure: Gastric emptying half-time
timeFrame: At Week 4
measure: Adverse events
timeFrame: 103 days
Other outcomes:
Locations:
Study officials:
affiliation: Theravance Biopharma
name: Deanna Nguyen, MD
role: STUDY_DIRECTOR
References: