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Phase 2 N=152 Randomized Triple-blind Treatment

Study to Assess the Efficacy of VLY-686 in Relieving Symptoms of Gastroparesis

Gastroparesis

Bottom Line

View on ClinicalTrials.gov: NCT02970968 ↗
Enrolled (actual)
152
Serious AEs
0.7%
Results posted
Aug 2024
Primary outcome: Primary: Change From Baseline in Average Nausea Severity — -1.25; -0.73 score on a scale (change from baseline) — p=.0099

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
VLY-686 (Tradipitant) (Drug); Placebo (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Vanda Pharmaceuticals
Primary completion
Nov 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline in Average Nausea Severity		 -1.25; -0.73 .0099 sig
SECONDARY
Weekly % Nausea-Free Days		 28.81; 15.00 .0160 sig
SECONDARY
Daily Average Vomiting Frequency, Change From Baseline		 -0.49; -0.26 .039 sig
SECONDARY
Gastroparesis Cardinal Symptom Index (GCSI), Change From Baseline		 -0.93; -0.58 .0223 sig
SECONDARY
PAGI-SYM, Change From Baseline		 -0.93; -0.65 .0497 sig
SECONDARY
CGI-S, Change From Baseline		 -1.13; -0.74 .0207 sig
SECONDARY
PGI-C		 2.66; 3.06 .0429 sig

Summary

This is a multicenter, randomized, double-blind, placebo-controlled study to be conducted in the United States. One hundred fifty (150) subjects diagnosed with gastroparesis, who satisfy the selection criteria for the study, will be randomized to one of two treatment groups, active or placebo.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with gastroparesis;
  • Subjects must agree to the use of contraception
  • Ability and acceptance to provide written informed consent;
  • Willing to participate in the pharmacogenomics sample collection;
  • Willing and able to comply with all study requirements and restrictions
  • Willing to not participate in any other interventional trial for the duration of their participation.

Exclusion Criteria

  • Another active disorder or treatment which could explain or contribute to symptoms in the opinion of the Investigator (including but not limited to gastric malignancy, neurological disorder, or heavy doses of strong anticholinergics);
  • Pregnancy or nursing;
  • History of intolerance and/or hypersensitivity to medications similar to VLY-686 (Tradipitant) and its accompanying excipients;
  • Use of another NK1 antagonist or palonosetron;
  • Exposure to any investigational medication, including placebo, within 60 days of the Baseline Visit;
  • Any other reason as determined by the Investigator which may lead to an unfavorable risk-benefit of study participation, may interfere with study compliance, or may confound study results.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02970968). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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