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

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ClinicalTrials.gov Identifier: NCT02970968
Recruitment Status : Recruiting
First Posted : November 22, 2016
Last Update Posted : April 27, 2018
Sponsor:
Information provided by (Responsible Party):
Vanda Pharmaceuticals

November 15, 2016
November 22, 2016
April 27, 2018
November 2016
December 2018   (Final data collection date for primary outcome measure)
Change in gastroparesis associated symptoms as assessed by patient reported diary [ Time Frame: 4 weeks ]
Same as current
Complete list of historical versions of study NCT02970968 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study to Assess the Efficacy of VLY-686 in Relieving Symptoms of Gastroparesis
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Assess the Efficacy of VLY-686 (Tradipitant) in Relieving Symptoms of Gastroparesis
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.

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.

The study is divided into two phases: the screening phase and the evaluation phase. The screening phase includes a screening visit to evaluate subjects' preliminary eligibility for the study. During the screening phase, subjects will collect diary data for at least 4 weeks. The evaluation phase includes 4 weeks of randomized double-blind treatment.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Gastroparesis
  • Drug: VLY-686 (Tradipitant)
    oral capsule
  • Other: Placebo
    placebo oral
  • Experimental: Study Drug
    VLY-686 (Tradipitant) oral capsule for 4 weeks.
    Intervention: Drug: VLY-686 (Tradipitant)
  • Placebo Comparator: Placebo
    Placebo oral capsule for 4 weeks.
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
Same as current
December 2018
December 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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);
  2. Pregnancy or nursing;
  3. History of intolerance and/or hypersensitivity to medications similar to VLY-686 (Tradipitant) and its accompanying excipients;
  4. Use of another NK1 antagonist or palonosetron;
  5. Exposure to any investigational medication, including placebo, within 60 days of the Baseline Visit;
  6. 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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
No
Contact: Vanda Pharmaceuticals 202-734-3400
United States
 
 
NCT02970968
VP-VLY-686-2301
No
Not Provided
Plan to Share IPD: No
Vanda Pharmaceuticals
Vanda Pharmaceuticals
Not Provided
Not Provided
Vanda Pharmaceuticals
April 2018

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