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

• Sponsor: Vanda Pharmaceuticals (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT02970968
• Collaborator: (none)
• Enrollment: 150
• Locations: 38
• Arms: 2
• Duration (Months): 25
• Patients Per Site: 3.9
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Gastroparesis	Drug: VLY-686 (Tradipitant); Other: Placebo	Phase 2

Detailed Description

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Assess the Efficacy of VLY-686 (Tradipitant) in Relieving Symptoms of Gastroparesis
• Study Start Date: Nov 1, 2016
• Anticipated Primary Completion Date: Dec 1, 2018
• Anticipated Study Completion Date: Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study Drug VLY-686 (Tradipitant) oral capsule for 4 weeks.	Drug: VLY-686 (Tradipitant); oral capsule
Placebo Comparator: Placebo Placebo oral capsule for 4 weeks.	Other: Placebo; placebo oral

Outcome Measures

Primary Outcome Measures

1. Change in gastroparesis associated symptoms as assessed by patient reported diary [4 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanda Investigational Site	Dothan	Alabama	United States	36305
2	Vanda Investigational Site	Huntsville	Alabama	United States	35801
3	Vanda Investigational Site	Tucson	Arizona	United States	85712
4	Vanda Investigational Site	Little Rock	Arkansas	United States	72211
5	Vanda Investigational Site	Chula Vista	California	United States	91910
6	Vanda Investigational Site	Los Angeles	California	United States	90095
7	Vanda Investigational Site	Palo Alto	California	United States	94305
8	Vanda Investigational Site	San Francisco	California	United States	94115
9	Vanda Investigational Site	Jacksonville	Florida	United States	32256
10	Vanda Investigational Site	Largo	Florida	United States	33777
11	Vanda Investigational Site	Miami	Florida	United States	33134
12	Vanda Investigational Site	Athens	Georgia	United States	30607
13	Vanda Investigational Site	Elgin	Illinois	United States	60123
14	Vanda Investigational Site	Indianapolis	Indiana	United States	46202
15	Vanda Investigational Site	Louisville	Kentucky	United States	40202
16	Vanda Investigational Site	Marrero	Louisiana	United States	70072
17	Vanda Investigational Site	Chevy Chase	Maryland	United States	20815
18	Vanda Investigational Site	Boston	Massachusetts	United States	02114
19	Vanda Investigational Site	Boston	Massachusetts	United States	02215
20	Vanda Investigational Site	Wyoming	Michigan	United States	49519
21	Vanda Investigational Site	Minneapolis	Minnesota	United States	55114
22	Vanda Investigational Site	Pascagoula	Mississippi	United States	39564
23	Vanda Investigational Site	Saint Louis	Missouri	United States	63104
24	Vanda Investigational Site	Great Neck	New York	United States	11023
25	Vanda Investigational Site	New York	New York	United States	10028
26	Vanda Investigational Site	Raleigh	North Carolina	United States	27612
27	Vanda Investigational Site	Salisbury	North Carolina	United States	28144
28	Vanda Investigational Site	Huber Heights	Ohio	United States	45424
29	Vanda Investigational Site	Mentor	Ohio	United States	44060
30	Vanda Investigational Site	Tulsa	Oklahoma	United States	74104
31	Vanda Investigational Site	Philadelphia	Pennsylvania	United States	19140
32	Vanda Investigational Site	Chattanooga	Tennessee	United States	37421
33	Vanda Investigational Site	Jackson	Tennessee	United States	38305
34	Vanda Investigational Site	Nashville	Tennessee	United States	37211
35	Vanda Investigational Site	El Paso	Texas	United States	79905
36	Vanda Investigational Site	Houston	Texas	United States	77030
37	Vanda Investigational Site	Richardson	Texas	United States	75082
38	Vanda Investigational Site	Norfolk	Virginia	United States	23502

Sponsors and Collaborators

• Vanda Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vanda Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT02970968
• Other Study ID Numbers: VP-VLY-686-2301
• First Posted: Nov 22, 2016
• Last Update Posted: Apr 27, 2018
• Last Verified: Apr 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Gastroparesis

Study Results

No Results Posted as of Apr 27, 2018