Phase 2 Study of Velusetrag in Diabetic or Idiopathic Gastroparesis

February 22, 2018 updated by: Theravance Biopharma

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85710
        • Desert Sun Clinical Research
    • California
      • Los Angeles, California, United States, 90036
        • Axis Clinical Trials
      • Ventura, California, United States, 93003
        • Ventura Clinical Trials
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Hospital
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • GI Associates & Endoscopy Center
    • Missouri
      • Mexico, Missouri, United States, 65265
        • Center for Digestive and Liver Diseases, Inc.
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates, LLC
    • Oregon
      • Portland, Oregon, United States, 97210
        • Northwest Gastroenterology Clinic
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Digestive and Liver Disease Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequence 1
3-way crossover of velusetrag or placebo
Drug: placebo
Drug: velusetrag dose 1
Other Names:
  • TD-5108
Drug: velusetrag dose 2
Other Names:
  • TD-5108
Drug: velusetrag dose 3
Other Names:
  • TD-5108
Experimental: Sequence 2
3-way crossover of velusetrag or placebo
Drug: placebo
Drug: velusetrag dose 1
Other Names:
  • TD-5108
Drug: velusetrag dose 2
Other Names:
  • TD-5108
Drug: velusetrag dose 3
Other Names:
  • TD-5108
Experimental: Sequence 3
3-way crossover of velusetrag or placebo
Drug: placebo
Drug: velusetrag dose 1
Other Names:
  • TD-5108
Drug: velusetrag dose 2
Other Names:
  • TD-5108
Drug: velusetrag dose 3
Other Names:
  • TD-5108
Experimental: Sequence 4
3-way crossover of velusetrag or placebo
Drug: placebo
Drug: velusetrag dose 1
Other Names:
  • TD-5108
Drug: velusetrag dose 2
Other Names:
  • TD-5108
Drug: velusetrag dose 3
Other Names:
  • TD-5108

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Gastric emptying half time (GE t1/2)
Time Frame: From baseline to week 5
From baseline to week 5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of lag time to gastric emptying (tlag)
Time Frame: From baseline to Week 5
From baseline to Week 5
Vital signs
Time Frame: From baseline to Day 49
Assess the safety and tolerability in subjects with diabetic or idiopathic gastroparesis
From baseline to Day 49
ECGs
Time Frame: From baseline to Day 49
From baseline to Day 49
Number of adverse events
Time Frame: From baseline to Day 49
From baseline to Day 49

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Theravance Biopharma

Collaborators

Alfasigma S.p.A.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

October 29, 2012

First Submitted That Met QC Criteria

October 31, 2012

First Posted (Estimate)

November 1, 2012

Study Record Updates

Last Update Posted (Actual)

February 26, 2018

Last Update Submitted That Met QC Criteria

February 22, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0093

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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