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:

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

History of Changes

Tracking Information
First Received Date ^ICMJE	October 29, 2012
Last Updated Date	March 5, 2013
Start Date ^ICMJE	December 2012
Estimated Primary Completion Date	December 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 31, 2012)	Gastric emptying half time (GE t1/2) [ Time Frame: From baseline to week 5 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01718938 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 31, 2012)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Multicenter, Phase II Study to Evaluate Velusetrag Effects on Gastric Emptying in Subjects With Diabetic or Idiopathic Gastroparesis
Official Title ^ICMJE	A Multicenter, Double-Blind, Randomized, Placebo- Controlled, Phase II Study to Evaluate Velusetrag Effects on Gastric Emptying in Subjects With Diabetic or Idiopathic Gastroparesis
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Gastroparesis
Intervention ^ICMJE	Drug: velusetrag dose 1 Drug: velusetrag dose 2 Drug: velusetrag dose 3 Drug: placebo
Study Arm (s)	Experimental: Sequence 1 3-way crossover of velusetrag or placebo Interventions: Drug: velusetrag dose 1 Drug: velusetrag dose 2 Drug: velusetrag dose 3 Drug: placebo Experimental: Sequence 2 3-way crossover of velusetrag or placebo Interventions: Drug: velusetrag dose 1 Drug: velusetrag dose 2 Drug: velusetrag dose 3 Drug: placebo Experimental: Sequence 3 3-way crossover of velusetrag or placebo Interventions: Drug: velusetrag dose 1 Drug: velusetrag dose 2 Drug: velusetrag dose 3 Drug: placebo Experimental: Sequence 4 3-way crossover of velusetrag or placebo Interventions: Drug: velusetrag dose 1 Drug: velusetrag dose 2 Drug: velusetrag dose 3 Drug: placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	32
Estimated Completion Date	February 2014
Estimated Primary Completion Date	December 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 64 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01718938
Other Study ID Numbers ^ICMJE	0093
Has Data Monitoring Committee	No
Responsible Party	Theravance, Inc.
Study Sponsor ^ICMJE	Theravance, Inc.
Collaborators ^ICMJE	Alfa Wassermann S.p.A.
Investigators ^ICMJE	Not Provided
Information Provided By	Theravance, Inc.
Verification Date	March 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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