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Evaluating the Safety and Efficacy of Tradipitant vs. Placebo in Idiopathic and Diabetic Gastroparesis

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ClinicalTrials.gov Identifier: NCT04028492
Recruitment Status : Recruiting
First Posted : July 22, 2019
Last Update Posted : March 22, 2024
Sponsor:
Information provided by (Responsible Party):
Vanda Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE July 10, 2019
First Posted Date  ICMJE July 22, 2019
Last Update Posted Date March 22, 2024
Actual Study Start Date  ICMJE August 20, 2019
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2019)		 Change from baseline in daily average nausea severity scores from the Gastroparesis Core Symptom Daily Diary (GCS-DD) [ Time Frame: 12 weeks ]
A daily symptom diary asking patients to rate their nausea on a Likert scale from 0-5 (0=none, 5= very severe).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2019)
  • Change from baseline in other average core gastroparesis symptoms from the Gastroparesis Core Symptom Daily Diary [ Time Frame: 12 weeks ]
    A patient reported daily symptom diary asking patients to rate their nausea on a Likert scale from 0-5 (0=none, 5= very severe). Other symptoms include vomiting, postprandial fullness, early satiety, and abdominal pain
  • Change from baseline in Patient Assessment of Gastrointestinal Disorders - Symptoms Severity Index (PAGI-SYM) [ Time Frame: 12 weeks ]
    PAGI-SYM is a patient reported outcome that measures specific symptoms of patients with upper gastrointestinal disorders such as gastroparesis, GERD, and dyspepsia on a 0-5 Likert Scale (0=none, 5=very severe).
  • Change from baseline in Patient Global Impression - Change (PGI-C) [ Time Frame: 12 weeks ]
    A patient reported outcome measuring a patient's rating of overall improvement after treatment on a 7 point scale that includes items "1=very much worse" and "7=very much improved"
  • Clinician Global Impression - Severity (CGI-S) [ Time Frame: 12 weeks ]
    A clinician reported outcome that measures the clinician's view of the patient's global functioning prior to and after initiating treatment. Symptom severity is measured on a 7 point scale including "1=normal, not at all ill" and "7=among the most extremely ill patients."
  • Safety and tolerability as measured by spontaneous reporting of adverse events (AEs) [ Time Frame: 12 weeks ]
    Safety will be monitored using clinical measures, vital signs, blood chemistry, hematology, urology, ECGs, and patient reported questionnaires.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluating the Safety and Efficacy of Tradipitant vs. Placebo in Idiopathic and Diabetic Gastroparesis
Official Title  ICMJE VP-VLY-686-3301: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Iii Study To Assess The Efficacy Of Tradipitant In Relieving Symptoms Of Gastroparesis
Brief Summary To investigate the safety and efficacy of tradipitant versus placebo in relieving nausea and other symptoms of gastroparesis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Idiopathic Gastroparesis
  • Diabetic Gastroparesis
  • Gastroparesis
Intervention  ICMJE
  • Drug: Tradipitant
    BID
  • Drug: Placebo
    BID
  • Drug: Open Label Tradipitant
    BID
Study Arms  ICMJE
  • Experimental: Tradipitant
    Oral Capsule
    Intervention: Drug: Tradipitant
  • Placebo Comparator: Placebo
    Oral Capsule
    Intervention: Drug: Placebo
  • Experimental: Open Label Tradipitant
    Oral Capsule
    Intervention: Drug: Open Label Tradipitant
Publications * Carlin JL, Polymeropoulos C, Camilleri M, Lembo A, Fisher M, Kupersmith C, Madonick D, Moszczynski P, Smieszek S, Xiao C, Birznieks G, Polymeropoulos MH. The Efficacy of Tradipitant in Patients With Diabetic and Idiopathic Gastroparesis in a Phase 3 Randomized Placebo-Controlled Clinical Trial. Clin Gastroenterol Hepatol. 2024 Jan 17:S1542-3565(24)00050-8. doi: 10.1016/j.cgh.2024.01.005. Online ahead of print.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 19, 2024)		 201
Original Estimated Enrollment  ICMJE
 (submitted: July 18, 2019)		 250
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosed with gastroparesis
  • Demonstrated delayed gastric emptying
  • Presence of moderate to severe nausea
  • Body Mass Index (BMI) of ≥18 and ≤40 kg/m2

Exclusion Criteria:

  • Another active disorder or treatment which could explain or contribute to symptoms of gastroparesis
  • A positive test for drugs of abuse at the screening or evaluation visits;
  • Exposure to any investigational medication in the past 60 days
  • Gastrectomy, fundoplication, vagotomy, pyloroplasty, bariatric surgery, or gastric stimulation device surgically implanted within the last year
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Vanda Pharmacuticals 202-734-3400 clinicaltrials@vandapharma.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04028492
Other Study ID Numbers  ICMJE VP-VLY-686-3301
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Vanda Pharmaceuticals
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Vanda Pharmaceuticals
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Vanda Pharmaceuticals Vanda Pharmaceuticals
PRS Account Vanda Pharmaceuticals
Verification Date March 2024

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