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

Gastroparesis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04028492
• Other study ID #: VP-VLY-686-3301
• Status: Recruiting
• Phase: Phase 3
• Start date: August 20, 2019
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Vanda Pharmaceuticals
• Contact: Vanda Pharmacuticals
• Phone: 202-734-3400
• Email: clinicaltrials[@]vandapharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To investigate the safety and efficacy of tradipitant versus placebo in relieving nausea and other symptoms of gastroparesis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 201
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Gastroparesis
• Gastroparesis
• Idiopathic Gastroparesis

Intervention

Drug:
• Tradipitant
BID
• Placebo
BID
• Open Label Tradipitant
BID

Locations

Country	Name	City	State
United States	Vanda Investigational Site	Birmingham	Alabama
United States	Vanda Investigational Site	Boston	Massachusetts
United States	Vanda Investigational Site	Boston	Massachusetts
United States	Vanda Investigational Site	Brooklyn	New York
United States	Vanda Investigational Site	Charlotte	North Carolina
United States	Vanda Investigational Site	Chattanooga	Tennessee
United States	Vanda Investigational Site	Chesterfield	Missouri
United States	Vanda Investigational Site	Chevy Chase	Maryland
United States	Vanda Investigational Site	Chula Vista	California
United States	Vanda Investigational Site	Columbus	Ohio
United States	Vanda Investigational Site	Edmond	Oklahoma
United States	Vanda Investigational Site	Houston	Texas
United States	Vanda Investigational Site	Houston	Texas
United States	Vanda Investigational Site	Huber Heights	Ohio
United States	Vanda Investigational Site	La Jolla	California
United States	Vanda Investigational Site	Las Vegas	Nevada
United States	Vanda Investigational Site	Little Rock	Arkansas
United States	Vanda Investigational Site	Los Angeles	California
United States	Vanda Investigational Site	Los Angeles	California
United States	Vanda Investigational Site	Louisville	Kentucky
United States	Vanda Investigational Site	Maitland	Florida
United States	Vanda Investigational Site	Marrero	Louisiana
United States	Vanda Investigational Site	Morrow	Georgia
United States	Vanda Investigational Site	Nashville	Tennessee
United States	Vanda Investigational Site	Palmetto Bay	Florida
United States	Vanda Investigational Site	Peoria	Arizona
United States	Vanda Investigational Site	Philadelphia	Pennsylvania
United States	Vanda Investigational Site	Plano	Texas
United States	Vanda Investigational Site	Raleigh	North Carolina
United States	Vanda Investigational Site	Salt Lake City	Utah
United States	Vanda Investigational Site	San Antonio	Texas
United States	Vanda Investigational Site	Tampa	Florida
United States	Vanda Investigational Site	Tulsa	Oklahoma
United States	Vanda Investigational Site	Wauconda	Illinois
United States	Vanda Investigational Site	West Des Moines	Iowa
United States	Vanda Investigational Site	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Vanda Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 Rando — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in daily average nausea severity scores from the Gastroparesis Core Symptom Daily Diary (GCS-DD)	A daily symptom diary asking patients to rate their nausea on a Likert scale from 0-5 (0=none, 5= very severe).	12 weeks
Secondary	Change from baseline in other average core gastroparesis symptoms from the Gastroparesis Core Symptom Daily Diary	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	12 weeks
Secondary	Change from baseline in Patient Assessment of Gastrointestinal Disorders - Symptoms Severity Index (PAGI-SYM)	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).	12 weeks
Secondary	Change from baseline in Patient Global Impression - Change (PGI-C)	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"	12 weeks
Secondary	Clinician Global Impression - Severity (CGI-S)	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."	12 weeks
Secondary	Safety and tolerability as measured by spontaneous reporting of adverse events (AEs)	Safety will be monitored using clinical measures, vital signs, blood chemistry, hematology, urology, ECGs, and patient reported questionnaires.	12 weeks

External Links

•   Study Website