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Phase 2 Study of Velusetrag in Diabetic or Idiopathic Gastroparesis

Primary Purpose

Gastroparesis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
velusetrag dose 1
velusetrag dose 2
velusetrag dose 3
placebo
Sponsored by
Theravance Biopharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroparesis focused on measuring Gastroparesis, Diabetic, Idiopathic, Delayed gastric emptying

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Desert Sun Clinical Research
  • Axis Clinical Trials
  • Ventura Clinical Trials
  • Indiana University Hospital
  • GI Associates & Endoscopy Center
  • Center for Digestive and Liver Diseases, Inc.
  • Wake Research Associates, LLC
  • Northwest Gastroenterology Clinic
  • Digestive and Liver Disease Specialists

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Sequence 1

Sequence 2

Sequence 3

Sequence 4

Arm Description

3-way crossover of velusetrag or placebo

3-way crossover of velusetrag or placebo

3-way crossover of velusetrag or placebo

3-way crossover of velusetrag or placebo

Outcomes

Primary Outcome Measures

Gastric emptying half time (GE t1/2)

Secondary Outcome Measures

Duration of lag time to gastric emptying (tlag)
Vital signs
Assess the safety and tolerability in subjects with diabetic or idiopathic gastroparesis
ECGs
Number of adverse events

Full Information

First Posted
October 29, 2012
Last Updated
February 22, 2018
Sponsor
Theravance Biopharma
Collaborators
Alfasigma S.p.A.
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1. Study Identification

Unique Protocol Identification Number
NCT01718938
Brief Title
Phase 2 Study of Velusetrag in Diabetic or Idiopathic Gastroparesis
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 Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Theravance Biopharma
Collaborators
Alfasigma S.p.A.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroparesis
Keywords
Gastroparesis, Diabetic, Idiopathic, Delayed gastric emptying

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sequence 1
Arm Type
Experimental
Arm Description
3-way crossover of velusetrag or placebo
Arm Title
Sequence 2
Arm Type
Experimental
Arm Description
3-way crossover of velusetrag or placebo
Arm Title
Sequence 3
Arm Type
Experimental
Arm Description
3-way crossover of velusetrag or placebo
Arm Title
Sequence 4
Arm Type
Experimental
Arm Description
3-way crossover of velusetrag or placebo
Intervention Type
Drug
Intervention Name(s)
velusetrag dose 1
Other Intervention Name(s)
TD-5108
Intervention Type
Drug
Intervention Name(s)
velusetrag dose 2
Other Intervention Name(s)
TD-5108
Intervention Type
Drug
Intervention Name(s)
velusetrag dose 3
Other Intervention Name(s)
TD-5108
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Gastric emptying half time (GE t1/2)
Time Frame
From baseline to week 5
Secondary Outcome Measure Information:
Title
Duration of lag time to gastric emptying (tlag)
Time Frame
From baseline to Week 5
Title
Vital signs
Description
Assess the safety and tolerability in subjects with diabetic or idiopathic gastroparesis
Time Frame
From baseline to Day 49
Title
ECGs
Time Frame
From baseline to Day 49
Title
Number of adverse events
Time Frame
From baseline to Day 49

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Desert Sun Clinical Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Axis Clinical Trials
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Ventura Clinical Trials
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Indiana University Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
GI Associates & Endoscopy Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Center for Digestive and Liver Diseases, Inc.
City
Mexico
State/Province
Missouri
ZIP/Postal Code
65265
Country
United States
Facility Name
Wake Research Associates, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Northwest Gastroenterology Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Digestive and Liver Disease Specialists
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33811761
Citation
Kuo B, Barnes CN, Nguyen DD, Shaywitz D, Grimaldi M, Renzulli C, Canafax D, Parkman HP. Velusetrag accelerates gastric emptying in subjects with gastroparesis: a multicentre, double-blind, randomised, placebo-controlled, phase 2 study. Aliment Pharmacol Ther. 2021 May;53(10):1090-1097. doi: 10.1111/apt.16344. Epub 2021 Apr 3.
Results Reference
derived

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Phase 2 Study of Velusetrag in Diabetic or Idiopathic Gastroparesis

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