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
|Condition or disease||Intervention/treatment|
|Gastroparesis Diabetic Gastroparesis||Drug: Tradipitant|
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.
-To treat a single patient with gastroparesis who has requested expanded access with tradipitant
- 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|
|Official Title:||VP-VLY-686-3303: SINGLE-PATIENT EXPANDED ACCESS PROTOCOL FOR TRADIPITANT IN A SINGLE PATIENT WITH GASTROPARESIS|
- Drug: Tradipitant
NK-1 Receptor antagonist
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
|Contact: Vanda Pharmaceuticalsfirstname.lastname@example.org|
|United States, Texas|
|Vanda Investigational Site||Available|
|Plano, Texas, United States, 75024|