A Multicenter, Phase II Study to Evaluate Velusetrag Effects on Gastric Emptying in Subjects With Diabetic or Idiopathic Gastroparesis

This study has been completed.
Sponsor:
Collaborator:
Alfa Wassermann S.p.A.
Information provided by (Responsible Party):
Theravance Biopharma Antibiotics, Inc.
ClinicalTrials.gov Identifier:
NCT01718938
First received: October 29, 2012
Last updated: July 31, 2014
Last verified: July 2014

October 29, 2012
July 31, 2014
December 2012
December 2013   (final data collection date for primary outcome measure)
Gastric emptying half time (GE t1/2) [ Time Frame: From baseline to week 5 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01718938 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Multicenter, Phase II Study to Evaluate Velusetrag Effects on Gastric Emptying in Subjects With Diabetic or Idiopathic Gastroparesis
A Multicenter, Double-Blind, Randomized, Placebo- Controlled, Phase II Study to Evaluate Velusetrag Effects on Gastric Emptying in Subjects With Diabetic or Idiopathic Gastroparesis

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Gastroparesis
  • Drug: velusetrag dose 1
  • Drug: velusetrag dose 2
  • Drug: velusetrag dose 3
  • Drug: placebo
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
February 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01718938
0093
No
Theravance Biopharma Antibiotics, Inc.
Theravance Biopharma Antibiotics, Inc.
Alfa Wassermann S.p.A.
Not Provided
Theravance Biopharma Antibiotics, Inc.
July 2014

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