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Phase 2 Study of Velusetrag in Diabetic or Idiopathic Gastroparesis

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ClinicalTrials.gov Identifier: NCT01718938
Recruitment Status : Completed
First Posted : November 1, 2012
Last Update Posted : February 26, 2018
Sponsor:
Collaborator:
Alfasigma S.p.A.
Information provided by (Responsible Party):
Theravance Biopharma

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Gastroparesis Drug: velusetrag dose 1 Drug: velusetrag dose 2 Drug: velusetrag dose 3 Drug: placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : December 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Sequence 1
3-way crossover of velusetrag or placebo
 Drug: velusetrag dose 1
Other Name: TD-5108

Drug: velusetrag dose 2
Other Name: TD-5108

Drug: velusetrag dose 3
Other Name: TD-5108

Drug: placebo
Experimental: Sequence 2
3-way crossover of velusetrag or placebo
 Drug: velusetrag dose 1
Other Name: TD-5108

Drug: velusetrag dose 2
Other Name: TD-5108

Drug: velusetrag dose 3
Other Name: TD-5108

Drug: placebo
Experimental: Sequence 3
3-way crossover of velusetrag or placebo
 Drug: velusetrag dose 1
Other Name: TD-5108

Drug: velusetrag dose 2
Other Name: TD-5108

Drug: velusetrag dose 3
Other Name: TD-5108

Drug: placebo
Experimental: Sequence 4
3-way crossover of velusetrag or placebo
 Drug: velusetrag dose 1
Other Name: TD-5108

Drug: velusetrag dose 2
Other Name: TD-5108

Drug: velusetrag dose 3
Other Name: TD-5108

Drug: placebo


Outcome Measures
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Primary Outcome Measures :
  1. Gastric emptying half time (GE t1/2) [ Time Frame: From baseline to week 5 ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01718938


Locations
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United States, Arizona
Desert Sun Clinical Research
Tucson, Arizona, United States, 85710
United States, California
Axis Clinical Trials
Los Angeles, California, United States, 90036
Ventura Clinical Trials
Ventura, California, United States, 93003
United States, Indiana
Indiana University Hospital
Indianapolis, Indiana, United States, 46202
United States, Mississippi
GI Associates & Endoscopy Center
Jackson, Mississippi, United States, 39202
United States, Missouri
Center for Digestive and Liver Diseases, Inc.
Mexico, Missouri, United States, 65265
United States, North Carolina
Wake Research Associates, LLC
Raleigh, North Carolina, United States, 27612
United States, Oregon
Northwest Gastroenterology Clinic
Portland, Oregon, United States, 97210
United States, Virginia
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Theravance Biopharma
Alfasigma S.p.A.
More Information
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Responsible Party: Theravance Biopharma
ClinicalTrials.gov Identifier: NCT01718938    
Other Study ID Numbers: 0093
First Posted: November 1, 2012    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018
Keywords provided by Theravance Biopharma:
Gastroparesis
Diabetic
Idiopathic
Delayed gastric emptying
Additional relevant MeSH terms:
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Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Paralysis
Neurologic Manifestations