A Multicenter, Phase II Study to Evaluate Velusetrag Effects on Gastric Emptying in Subjects With Diabetic or Idiopathic Gastroparesis

This study has been completed.
Sponsor:
Collaborator:
Alfa Wassermann S.p.A.
Information provided by (Responsible Party):
Theravance Biopharma Antibiotics, Inc. ( Theravance Biopharma R & D, Inc. )
ClinicalTrials.gov Identifier:
NCT01718938
First received: October 29, 2012
Last updated: September 3, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Gastroparesis
Drug: velusetrag dose 1
Drug: velusetrag dose 2
Drug: velusetrag dose 3
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Randomized, Placebo- Controlled, Phase II Study to Evaluate Velusetrag Effects on Gastric Emptying in Subjects With Diabetic or Idiopathic Gastroparesis

Further study details as provided by Theravance Biopharma Antibiotics, Inc.:

Primary Outcome Measures:
  • Gastric emptying half time (GE t1/2) [ Time Frame: From baseline to week 5 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of lag time to gastric emptying (tlag) [ Time Frame: From baseline to Week 5 ] [ Designated as safety issue: No ]
  • Vital signs [ Time Frame: From baseline to Day 49 ] [ Designated as safety issue: Yes ]
    Assess the safety and tolerability in subjects with diabetic or idiopathic gastroparesis

  • ECGs [ Time Frame: From baseline to Day 49 ] [ Designated as safety issue: Yes ]
  • Number of adverse events [ Time Frame: From baseline to Day 49 ] [ Designated as safety issue: Yes ]

Enrollment: 34
Study Start Date: December 2012
Study Completion Date: February 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sequence 1
3-way crossover of velusetrag or placebo
Drug: velusetrag dose 1 Drug: velusetrag dose 2 Drug: velusetrag dose 3 Drug: placebo
Experimental: Sequence 2
3-way crossover of velusetrag or placebo
Drug: velusetrag dose 1 Drug: velusetrag dose 2 Drug: velusetrag dose 3 Drug: placebo
Experimental: Sequence 3
3-way crossover of velusetrag or placebo
Drug: velusetrag dose 1 Drug: velusetrag dose 2 Drug: velusetrag dose 3 Drug: placebo
Experimental: Sequence 4
3-way crossover of velusetrag or placebo
Drug: velusetrag dose 1 Drug: velusetrag dose 2 Drug: velusetrag dose 3 Drug: placebo

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01718938

Locations
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 R & D, Inc.
Alfa Wassermann S.p.A.
  More Information

No publications provided

Responsible Party: Theravance Biopharma Antibiotics, Inc. ( Theravance Biopharma R & D, Inc. )
ClinicalTrials.gov Identifier: NCT01718938     History of Changes
Other Study ID Numbers: 0093
Study First Received: October 29, 2012
Last Updated: September 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Theravance Biopharma Antibiotics, Inc.:
Gastroparesis
Diabetic
Idiopathic
Delayed gastric emptying

Additional relevant MeSH terms:
Gastroparesis
Digestive System Diseases
Gastrointestinal Diseases
Neurologic Manifestations
Paralysis
Signs and Symptoms
Stomach Diseases

ClinicalTrials.gov processed this record on October 20, 2014