A Multicenter, Phase II Study to Evaluate Velusetrag Effects on Gastric Emptying in Subjects With Diabetic or Idiopathic Gastroparesis
This study is currently recruiting participants.
Verified March 2013 by Theravance, Inc.
Sponsor:
Theravance, Inc.
Collaborator:
Alfa Wassermann S.p.A.
Information provided by (Responsible Party):
Theravance, Inc.
ClinicalTrials.gov Identifier:
NCT01718938
First received: October 29, 2012
Last updated: March 5, 2013
Last verified: March 2013
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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, 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 ]
| Estimated Enrollment: | 32 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | February 2014 |
| Estimated 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) > 180 minutes as determined by [13C]-octanoate breath test, at Screening
- Upper gastrointestinal (UGI) obstruction ruled out by endoscopy or other imaging since 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01718938
Locations
| United States, California | |
| Axis Clinical Trials | Recruiting |
| Los Angeles, California, United States, 90036 | |
| Contact: Lydie Hazan, MD 310-289-8242 | |
| Principal Investigator: Lydie Hazan, MD | |
| United States, Missouri | |
| Center for Digestive and Liver Diseases, Inc. | Recruiting |
| Mexico, Missouri, United States, 65265 | |
| Contact: Glenn L. Gordon, MD 573-581-7196 | |
| Principal Investigator: Glenn L. Gordon, MD | |
| United States, North Carolina | |
| Wake Research Associates, LLC | Recruiting |
| Raleigh, North Carolina, United States, 27612 | |
| Contact: Charles Barish, MD 919-721-2514 | |
| Principal Investigator: Charles F Barish, MD | |
| United States, Oregon | |
| Northwest Gastroenterology Clinic | Recruiting |
| Portland, Oregon, United States, 97210 | |
| Contact: R. William Bennetts, MD 503-229-7137 | |
| Principal Investigator: R William Bennetts, MD | |
| United States, Virginia | |
| Digestive and Liver Disease Specialists | Recruiting |
| Norfolk, Virginia, United States, 23502 | |
| Contact: Syed Thiwan, MD 757-466-0165 | |
| Principal Investigator: Syed Thiwan, MD | |
Sponsors and Collaborators
Theravance, Inc.
Alfa Wassermann S.p.A.
More Information
No publications provided
| Responsible Party: | Theravance, Inc. |
| ClinicalTrials.gov Identifier: | NCT01718938 History of Changes |
| Other Study ID Numbers: | 0093 |
| Study First Received: | October 29, 2012 |
| Last Updated: | March 5, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Theravance, Inc.:
|
Gastroparesis Diabetic Idiopathic Delayed gastric emptying |
Additional relevant MeSH terms:
|
Gastroparesis Stomach Diseases Gastrointestinal Diseases Digestive System Diseases |
Paralysis Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013