Diabetic or Idiopathic Gastroparesis

  • STATUS
    Recruiting
Updated on 25 March 2021

Summary

Diabetic or Idiopathic Gastroparesis

Description

0099 : 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.

Details
Clinical Study IdentifierTX141618
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

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 ≥2.5 and <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, defined as a gastric emptying retention >10% at 4 hours, as measured by 99mTc gastric emptying scintigraphy (GES) at Screening (unless a comparable, qualifying 4-hour GES within 1 year of Screening is available)
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 72 hours prior to GES during Screening, if applicable, and 72 hours prior to start of the Baseline period and then throughout the duration of the study
GCSI-DD 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 >10%
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 6 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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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