At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Effect of Antihistamines on Ureteral Stent-Related Symptoms: Randomized Controlled Trial
In Brief
A Phase 2 clinical trial evaluating Fexofenadine Hcl 180Mg Tab and Placebo for Nephrolithiasis. Completed, enrolled 78 participants across 1 site.
Detailed Summary
This is a prospective, double-blind, randomized, open-label, single-center trial of up to 78 participants who are adult patients (aged 18-80 years) and are undergoing unilateral retrograde ureteroscopy with planned ureteral stent placement for treatment of urinary tract stones. Eligible patients will be randomly and divided into two groups in a 1:1 ratio. Group A will receive fexofenadine 180 mg once daily in addition to standard of care treatment. Group B will receive placebo in addition to standard of care treatment. The routine standard of care treatment will consist of oral non-steroidal anti-inflammatory drugs (NSAIDs). The primary outcomes of the study are the Ureteral Stent Symptom Questionnaire (USSQ) urinary symptom score and pain score. Secondary outcomes include (i) number of office phone calls due to urinary symptoms; (ii) duration of analgesic use; (iii) duration and quantity of narcotic use; (iv) number of emergency department visits; (v) drug-related adverse effects; (vi) other domains of the USSQ.
Study Details
Timeline
Interventions
Fexofenadine 180mg tablet to be taken orally once a day until stent removal.
Placebo tablet to be taken orally once a day until stent removal.