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SINGLE-PATIENT EXPANDED ACCESS PROTOCOL FOR TRADIPITANT IN A SINGLE PATIENT WITH GASTROPARESIS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04474990
Expanded Access Status : Available
First Posted : July 17, 2020
Last Update Posted : July 17, 2020
Sponsor:
Information provided by (Responsible Party):
Vanda Pharmaceuticals

Brief Summary:
Primary Objective: To treat a single patient with gastroparesis who has requested expanded access with tradipitant

Condition or disease Intervention/treatment
Gastroparesis Diabetic Gastroparesis Drug: Tradipitant

Detailed Description:

This is a single-patient extended access treatment protocol to be conducted in the United States. Investigator-Physician has determined patient satisfies expanded access inclusion criteria and has requested expanded access to tradipitant.

Patient will be given open label tradipitant 85 mg to be taken twice daily at 12 hour intervals for long term treatment. Patient can fill out daily web-based symptom diaries on a voluntary basis and report any adverse events to Investigator-Physician.

Primary Objective:

-To treat a single patient with gastroparesis who has requested expanded access with tradipitant

Secondary Objectives:

  • To monitor the efficacy of tradipitant in reducing individual symptoms associated with gastroparesis in this single patient
  • To monitor the safety of tradipitant in a patient with gastroparesis by assessing adverse events in this single patient

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Study Type : Expanded Access
Expanded Access Type : Individual Patients
Official Title: VP-VLY-686-3303: SINGLE-PATIENT EXPANDED ACCESS PROTOCOL FOR TRADIPITANT IN A SINGLE PATIENT WITH GASTROPARESIS



Intervention Details:
  • Drug: Tradipitant
    NK-1 Receptor antagonist

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Identified subject who requested expanded access
  • Diagnosed with gastroparesis
  • Demonstrated delayed gastric emptying
  • Presence of moderate to severe nausea
  • Patient does not qualify for or does not have access to other clinical trials with tradipitant;

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 other than tradipitant
  • Gastrectomy, fundoplication, vagotomy, pyloroplasty, bariatric surgery, or gastric stimulation device surgically implanted within the last year
  • Any other reason as determined by the Investigator which may lead to an unfavorable risk-benefit ratio to treatment;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04474990


Contacts
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Contact: Vanda Pharmaceuticals 2027343400 clinicaltrials@vandapharma.com

Locations
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United States, Texas
Vanda Investigational Site Available
Plano, Texas, United States, 75024
Contact    202-734-3400      
Sponsors and Collaborators
Vanda Pharmaceuticals
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Responsible Party: Vanda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04474990    
Other Study ID Numbers: VP-VLY-686-3303
First Posted: July 17, 2020    Key Record Dates
Last Update Posted: July 17, 2020
Last Verified: July 2020
Keywords provided by Vanda Pharmaceuticals:
tradipitant
gastroparesis
idiopathic
diabetic
nausea
vomiting
stomach
motility
functional
NK-1 antagonist
neurokinin 1 receptor
substance p
expanded access
Additional relevant MeSH terms:
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Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations