Lixivaptan in a Single Subject With Intractable Pain Due to Polycystic Kidney Disease
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|ClinicalTrials.gov Identifier: NCT03717181|
Recruitment Status : Active, not recruiting
First Posted : October 24, 2018
Last Update Posted : January 29, 2021
|Condition or disease||Intervention/treatment||Phase|
|Polycystic Kidney||Drug: Lixivaptan||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Expanded Access Use of Lixivaptan in a Single Subject With Intractable Pain Due to Polycystic Kidney Disease|
|Actual Study Start Date :||May 22, 2019|
|Actual Primary Completion Date :||November 4, 2020|
|Estimated Study Completion Date :||February 28, 2021|
Lixivaptan capsule, up to 200 mg PO BID
Daily dose of lixivaptan optimized using a predetermined titration protocol.
- Pain intensity [ Time Frame: 6 months ]Assessment of abdominal pain intensity on a standard numerical rating scale of pain captured as a whole number between 0 and 10 where 0 is "no pain" and 10 is "worst pain imaginable". Improvement in pain is represented as a lower pain intensity score. There are no subscales.
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): NCT03717181
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Marie C Hogan, MD, PhD||Mayo Clinic|