A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy, Safety, and Tolerability of Velusetrag for the Treatment of Diabetic or Idiopathic Gastroparesis

Status: Completed
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: No
View:

• Symptoms of gastroparesis (eg, nausea, early satiety, fullness, bloating, upper abdominal pain, retching or vomiting) for at least 3 months prior to Screening

• Composite score ≥2and <5 on nausea, bloating, feeling excessively full after meals, and not able to finish a normal-sized meal items (on the GCSI-2W) at Screening

• Delayed gastric emptying by either GES (gastric emptying scintigraphy) or GEBT(gastric emptying breath test)

• Upper gastrointestinal obstruction ruled out by endoscopy or other imaging (eg, computed tomography) after the onset of gastroparesis symptoms

• Willing to abstain from prohibited medications, including but not limited to, anticholinergics, acetylcholinesterase antagonists, or promotility medications (eg, metoclopramide, domperidone, prucalopride, erythromycin) for: 24 hours prior to gastric emptying test during Screening, if applicable; 24 hours prior to start of the Baseline period; and during the Baseline Period

• GCSI-24H 7-day mean composite score ≥2.5 and <5 at Day 1

Time Frame
Start Date: December 2014
Completion Date: June 2017
Participants
Target number of participants: 233
Treatments
Experimental: Velusetrag 5mg
Velusetrag 5mg capsules QD (once daily) x 12 weeks
Experimental: Velusetrag 15mg
Velusetrag 15mg capsules QD x 12 weeks
Experimental: Velusetrag 30mg
Velusetrag 30mg capsules QD x 12 weeks
Placebo Comparator: Placebo
Placebo capsules QD x 12 weeks
Authors
Dennis K. Buth, Robert Orr, Kiran Jagarlamudi, Peter Moses, John Lowe, Gregory Wiener, William Reid Litchfield, Ziad Younes, Peter Varunok, Daniel Pambianco, Nabil Andrawis, Luis C. Quintero, Hiroshi Mashimo, David Robertson, Ronald Fogel, Michael Schulman, Bob Souder, Ravi Ganeshappa, Ashwin Kurian, Taddese Desta, Jeffrey Williams, Anthony Lembo, Robert Henihan, Braden Kuo, Ravi Moparty, Donato R. Ricci, Kimball Johnson, Sushma Gorrela, Tuba Esfandyari, Peter Weissman, Henry Parkman, Raul Tamayo, Robert Murphy, Todd Williams, Harvey Tatum, Jennifer Christie, Allan Coates, Thomas Abell, Ricardo Presas, John Baber, John Wo, Robert Herring, Felix Tiongco, April Grudell, Robert Holmes, Syed Thiwan, Maciej Kierzkiewicz, Wieslaw Zarzycki, M. Tarek Al-Assi, Vaclav Hejda, Michael Jones, Richard Jackson, Richard Krause, Greger Lindberg, Mazen Jamal, Anna Jungwirthová, Per Hellström, Elizbieta Bandurska-Stankiewicz, William R. Bennetts, Ammar Hemaiden, Pankaj Pascricha, Beata Gawdis-Wojnorska, Alexander Dela Llana, Jakub Mikes, Łukasz Bochynski, Michal Walczak, Piotr Drobinski, Piotr Gietka, Hans Törnblom, Eamonn Quigley, Paul Hellstern, Bal Raj Bhandari, Pavel Drastich, Richard McCallum
Related Therapeutic Areas
Sponsors
Leads: Theravance Biopharma
Collaborators: Alfasigma S.p.A.

This content was sourced from clinicaltrials.gov

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