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Completed

NCT Number: NCT01718938

Phase 2 Study of Velusetrag in Diabetic or Idiopathic Gastroparesis

This is a multicenter, randomized, double-blind, incomplete block, three period fixed sequence crossover, multicenter, placebo-controlled study. The study will assess three oral doses of velusetrag (5 mg, 15 mg, and/or 30 mg) or placebo, administered once daily in three periods of 1-week duration each, with a 1-week washout period between treatment periods, in subjects with diabetic or idiopathic gastroparesis.

Study 0093 will evaluate the effect of velusetrag in subjects with diabetic or idiopathic gastroparesis by assessing changes in gastric emptying.

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Key information

Conditions

Gastroparesis Digestive System Diseases Gastrointestinal Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomach Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Desert Sun Clinical Research, Tucson, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Symptoms of gastroparesis (e.g., nausea, early satiety, fullness, bloating, upper abdominal pain, retching or vomiting) for at least 3 months prior to Screening
  • Body Mass Index (BMI) between 18 and 35 kg/m2, inclusive
  • Gastroparesis Cardinal Symptom Index (GCSI-2W) composite score ≥2 and ≤4 at Screening
  • Delayed gastric emptying, defined as a gastric emptying half-time (GE t1/2) > 160 minutes as determined by [13C]-octanoate breath test, at Screening
  • Upper gastrointestinal (UGI) obstruction ruled out by endoscopy or other imaging reasonably proximal to the diagnosis of gastroparesis

Exclusion criteria

  • Acute severe gastroenteritis within 2 weeks prior to Screening
  • History of gastric outlet obstruction
  • Prior history of gastric surgery, including but not limited to gastrectomy, gastric bypass, gastric banding, pyloroplasty, vagotomy, or fundoplication
  • Recurrent vomiting, defined as vomiting more than 2 days per week
  • Hospitalization for treatment of gastroparesis or complications of diabetes within 4 weeks prior to Screening
  • Presence of thyroid dysfunction not controlled by treatment. Subjects with abnormal thyroid stimulating hormone (TSH), hypothyroidism, or hyperthyroidism at Screening
  • If Type 1 or Type 2 diabetic, a glycosylated hemoglobin (HbA1c) level >10% or a glucose > 250 mg/dL at Screening

Treatment and study plan

velusetrag dose 1

Drug

Other names: TD-5108

velusetrag dose 2

Drug

Other names: TD-5108

velusetrag dose 3

Drug

Other names: TD-5108

Placebo

Drug

Primary outcomes

  1. Gastric emptying half time (GE t1/2)

    Time frame: From baseline to week 5

Secondary outcomes

  1. Duration of lag time to gastric emptying (tlag)

    Time frame: From baseline to Week 5

  2. Vital signs

    Time frame: From baseline to Day 49

    Assess the safety and tolerability in subjects with diabetic or idiopathic gastroparesis

  3. ECGs

    Time frame: From baseline to Day 49

  4. Number of adverse events

    Time frame: From baseline to Day 49

Sponsors and collaborators

Lead sponsor

Theravance Biopharma

Industry

Collaborators

  • Alfasigma S.p.A.

Registry information

Official study title

A Multicenter, Double-Blind, Randomized, Placebo- Controlled, Phase 2 Study to Evaluate Velusetrag Effects on Gastric Emptying in Subjects With Diabetic or Idiopathic Gastroparesis

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Nov 1, 2012
Registry last updated
Feb 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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