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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
Sponsor:
Collaborator:
Alfasigma S.p.A.
Information provided by (Responsible Party):
Theravance Biopharma

Tracking Information
First Submitted Date  ICMJE October 29, 2012
First Posted Date  ICMJE November 1, 2012
Last Update Posted Date February 26, 2018
Study Start Date  ICMJE December 2012
Actual 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2012)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 2 Study of Velusetrag in Diabetic or Idiopathic Gastroparesis
Official Title  ICMJE A Multicenter, Double-Blind, Randomized, Placebo- Controlled, Phase 2 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  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Gastroparesis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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 * 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 Apr 3. doi: 10.1111/apt.16344. [Epub ahead of print]

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: July 31, 2014)
34
Original Estimated Enrollment  ICMJE
 (submitted: October 31, 2012)
32
Actual Study Completion Date  ICMJE February 2014
Actual 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) > 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01718938
Other Study ID Numbers  ICMJE 0093
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Theravance Biopharma
Study Sponsor  ICMJE Theravance Biopharma
Collaborators  ICMJE Alfasigma S.p.A.
Investigators  ICMJE Not Provided
PRS Account Theravance Biopharma
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP