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

Phase 3

Recruiting

• Conditions: Gastroparesis; Idiopathic Gastroparesis; Diabetic Gastroparesis
• Interventions: Drug: Placebo; Drug: Open Label Tradipitant; Drug: Tradipitant

• Registration Number: NCT04028492
• Lead Sponsor: Vanda Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Study First Submitted: 2019-07-10
• Study First Submitted QC: 2019-07-18
• Study First Posted: 2019-07-22
• Study Start: 2019-08-20
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-22
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 201

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Oral Capsule
Open Label Tradipitant	Open Label Tradipitant	Oral Capsule
Tradipitant	Tradipitant	Oral Capsule

Primary Outcome Measures

Name	Time	Method
Change from baseline in daily average nausea severity scores from the Gastroparesis Core Symptom Daily Diary (GCS-DD)	12 weeks	A daily symptom diary asking patients to rate their nausea on a Likert scale from 0-5 (0=none, 5= very severe).

Secondary Outcome Measures

Name	Time	Method
Change from baseline in other average core gastroparesis symptoms from the Gastroparesis Core Symptom Daily Diary	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)	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)	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)	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)	12 weeks	Safety will be monitored using clinical measures, vital signs, blood chemistry, hematology, urology, ECGs, and patient reported questionnaires.

Trial Locations

Locations (1)

Vanda Investigational Site; 🇺🇸 Salt Lake City, Utah, United States