CLINICAL TRIALS PROFILE FOR VELUSETRAG
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Clinical Trials for Velusetrag
| Trial ID | Title | Status | Sponsor | Phase | Summary |
|---|---|---|---|---|---|
| NCT01467726 ↗ | Safety, Pharmacokinetics and Pharmacodynamics of Velusetrag in Healthy Elderly Subjects | Completed | Theravance Biopharma | Phase 1 | This is a Phase 1, Randomized, Placebo-Controlled, Double-Blind, Study of Safety, Pharmacokinetics and Pharmacodynamics of Velusetrag in Healthy Elderly Subjects. |
| NCT01467726 ↗ | Safety, Pharmacokinetics and Pharmacodynamics of Velusetrag in Healthy Elderly Subjects | Completed | Theravance Biopharma R & D, Inc. | Phase 1 | This is a Phase 1, Randomized, Placebo-Controlled, Double-Blind, Study of Safety, Pharmacokinetics and Pharmacodynamics of Velusetrag in Healthy Elderly Subjects. |
| NCT01718938 ↗ | Phase 2 Study of Velusetrag in Diabetic or Idiopathic Gastroparesis | Completed | Alfa Wassermann S.p.A. | Phase 2 | 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. |
| NCT01718938 ↗ | Phase 2 Study of Velusetrag in Diabetic or Idiopathic Gastroparesis | Completed | Alfasigma S.p.A. | Phase 2 | 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. |
| NCT01718938 ↗ | Phase 2 Study of Velusetrag in Diabetic or Idiopathic Gastroparesis | Completed | Theravance Biopharma | Phase 2 | 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. |
| NCT01718938 ↗ | Phase 2 Study of Velusetrag in Diabetic or Idiopathic Gastroparesis | Completed | Theravance Biopharma R & D, Inc. | Phase 2 | 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. |
| NCT02267525 ↗ | The Diabetic and Idiopathic Gastroparesis Efficacy, Safety, and Tolerability (DIGEST) Study | Completed | Alfa Wassermann S.p.A. | Phase 2 | Study 0099 explores the efficacy and safety of multiple doses of velusetrag in the treatment of symptoms in subjects with diabetic or idiopathic gastroparesis. Three dose levels of velusetrag will be evaluated and compared to placebo for approximately 12 weeks of therapy. In addition, the study will be used to evaluate the psychometric properties of the Gastroparesis Rating Scale (GRS), a daily patient-reported outcome (PRO) measure. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Summary |
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