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
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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 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 |

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 |
- Gastric emptying half time (GE t1/2) [ Time Frame: From baseline to week 5 ]
- Duration of lag time to gastric emptying (tlag) [ Time Frame: 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
- ECGs [ Time Frame: From baseline to Day 49 ]
- Number of adverse events [ Time Frame: From baseline to Day 49 ]

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

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
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 |
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 |
Gastroparesis Diabetic Idiopathic Delayed gastric emptying |
Gastroparesis Stomach Diseases Gastrointestinal Diseases |
Digestive System Diseases Paralysis Neurologic Manifestations |