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

Sponsor

Vanda Pharmaceuticals (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04028492

Collaborator

(none)

250

Enrollment

Locations

Arms

24.4

Anticipated Duration (Months)

4.7

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Gastroparesis Diabetic Gastroparesis Gastroparesis	Drug: Tradipitant Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

250 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Aug 20, 2019

Anticipated Primary Completion Date :

Sep 1, 2021

Anticipated Study Completion Date :

Sep 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tradipitant Oral Capsule	Drug: Tradipitant BID
Placebo Comparator: Placebo Oral Capsule	Drug: Placebo BID

Arm

Intervention/Treatment

Experimental: Tradipitant

Oral Capsule

Drug: Tradipitant

BID

Placebo Comparator: Placebo

Oral Capsule

Drug: Placebo

BID

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanda Investigational Site	Birmingham	Alabama	United States	53244
2	Vanda Investigational Site	Peoria	Arizona	United States	85381
3	Vanda Investigational Site	Little Rock	Arkansas	United States	72211
4	Vanda Investigational Site	Chula Vista	California	United States	91910
5	Vanda Investigational Site	La Jolla	California	United States	92093
6	Vanda Investigational Site	Los Angeles	California	United States	90017
7	Vanda Investigational Site	Los Angeles	California	United States	90026
8	Vanda Investigational Site	Los Angeles	California	United States	90036
9	Vanda Investigational Site	Redwood City	California	United States	94063
10	Vanda Investigational Site	Denver	Colorado	United States	80220
11	Vanda Investigational Site	Wheat Ridge	Colorado	United States	80033
12	Vanda Investigational Site	Maitland	Florida	United States	32751
13	Vanda Investigational Site	Miami	Florida	United States	33134
14	Vanda Investigational Site	Miami	Florida	United States	33165
15	Vanda Investigational Site	Palmetto Bay	Florida	United States	33157
16	Vanda Investigational Site	Tampa	Florida	United States	33613
17	Vanda Investigational Site	Morrow	Georgia	United States	30260
18	Vanda Investigational Site	Stone Mountain	Georgia	United States	30083
19	Vanda Investigational Site	Wauconda	Illinois	United States	60084
20	Vanda Investigational Site	Wichita	Kansas	United States	67214
21	Vanda Investigational Site	Louisville	Kentucky	United States	40202
22	Vanda Investigational Site	Marrero	Louisiana	United States	70072
23	Vanda Investigational Site	Baltimore	Maryland	United States	21224
24	Vanda Investigational Site	Chevy Chase	Maryland	United States	20815
25	Vanda Investigational Site	Boston	Massachusetts	United States	02114
26	Vanda Investigational Site	Boston	Massachusetts	United States	02115
27	Vanda Investigational Site	Farmington Hills	Michigan	United States	48334
28	Vanda Investigational Site	Chesterfield	Missouri	United States	63005
29	Vanda Investigational Site	Omaha	Nebraska	United States	68134
30	Vanda Investigational Site	Las Vegas	Nevada	United States	89121
31	Vanda Investigational Site	Bronx	New York	United States	10455
32	Vanda Investigational Site	Brooklyn	New York	United States	11201
33	Vanda Investigational Site	New York	New York	United States	10022
34	Vanda Investigational Site	Charlotte	North Carolina	United States	28209
35	Vanda Investigational Site	Raleigh	North Carolina	United States	27612
36	Vanda Investigational Site	Columbus	Ohio	United States	43214
37	Vanda Investigational Site	Huber Heights	Ohio	United States	45424
38	Vanda Investigational Site	Edmond	Oklahoma	United States	73034
39	Vanda Investigational Site	Tulsa	Oklahoma	United States	74104
40	Vanda Investigational Site	Philadelphia	Pennsylvania	United States	19104
41	Vanda Investigational Site	Philadelphia	Pennsylvania	United States	19140
42	Vanda Investigational Site	Charleston	South Carolina	United States	29406
43	Vanda Investigational Site	Chattanooga	Tennessee	United States	37421
44	Vanda Investigational Site	Jackson	Tennessee	United States	38305
45	Vanda Investigational Site	Nashville	Tennessee	United States	37211
46	Vanda Investigational Site	Arlington	Texas	United States	76012
47	Vanda Investigational Site	Houston	Texas	United States	77043
48	Vanda Investigational Site	Houston	Texas	United States	77084
49	Vanda Investigational Site	Plano	Texas	United States	75024
50	Vanda Investigational Site	San Antonio	Texas	United States	78215
51	Vanda Investigational Site	Salt Lake City	Utah	United States	84132
52	Vanda Investigational Site	West Jordan	Utah	United States	84088
53	Vanda Investigational Site	Spokane	Washington	United States	99202