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

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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

Tracking Information
First Submitted Date July 13, 2020
First Posted Date July 17, 2020
Last Update Posted Date July 17, 2020
 
Descriptive Information
Brief Title SINGLE-PATIENT EXPANDED ACCESS PROTOCOL FOR TRADIPITANT IN A SINGLE PATIENT WITH GASTROPARESIS
Official Title VP-VLY-686-3303: SINGLE-PATIENT EXPANDED ACCESS PROTOCOL FOR TRADIPITANT IN A SINGLE PATIENT WITH GASTROPARESIS
Brief Summary Primary Objective: To treat a single patient with gastroparesis who has requested expanded access with 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
Study Type Expanded Access
Expanded Access Type Individual Patients
Condition
  • Gastroparesis
  • Diabetic Gastroparesis
Intervention Drug: Tradipitant
NK-1 Receptor antagonist
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status Available
Eligibility 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;
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Contacts
Contact: Vanda Pharmaceuticals 2027343400 clinicaltrials@vandapharma.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04474990
Other Study ID Numbers VP-VLY-686-3303
Responsible Party Vanda Pharmaceuticals
Study Sponsor Vanda Pharmaceuticals
Collaborators Not Provided
Investigators Not Provided
PRS Account Vanda Pharmaceuticals
Verification Date July 2020