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Fexofenadine Hcl 180Mg Tab for Kidney Stones

Phase 2
Recruiting
Led By Ojas Shah, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult patients (aged 18-80 years) who are undergoing unilateral retrograde ureteroscopy with planned ureteral stent placement for treatment of urinary tract stones
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at time of stent removal (1-2 weeks after surgery)
Awards & highlights

Study Summary

This trialwill study if adding a medication to routine care can reduce symptoms and pain from a urinary tract stone procedure.

Who is the study for?
Adults aged 18-80 undergoing ureteroscopy with stent placement for urinary stones can join. Excluded are those with severe kidney disease, pregnant or breastfeeding women, patients needing bilateral procedures, single/transplanted kidneys, antihistamine allergies, and certain pre-existing conditions or medication use.Check my eligibility
What is being tested?
The trial tests if Fexofenadine (an antihistamine) reduces symptoms from a ureteral stent compared to a placebo. Participants will be split evenly into two groups; one gets the drug daily plus standard painkillers (NSAIDs), the other gets a fake pill plus NSAIDs.See study design
What are the potential side effects?
Possible side effects include reactions typical of antihistamines such as drowsiness, dry mouth, dizziness and may involve more specific issues due to interaction with stent-related symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am an adult between 18 and 80 years old getting a procedure for urinary stones with a stent placement.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at time of initial visit (prior to surgery - baseline), at time of stent removal (1-2 weeks after surgery), at time of follow-up (4-6 weeks after stent removal)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at time of initial visit (prior to surgery - baseline), at time of stent removal (1-2 weeks after surgery), at time of follow-up (4-6 weeks after stent removal) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in USSQ body pain score
Change in USSQ urinary symptom score
Secondary outcome measures
Duration of NSAID use
Number of drug-related adverse effects
Number of emergency department visits
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: FexofenadineExperimental Treatment1 Intervention
Participants in this arm will receive fexofenadine 180mg once daily, in addition to standard of care pain medications (NSAIDs).
Group II: PlaceboPlacebo Group1 Intervention
Participants in this arm will receive placebo once daily, in addition to standard of care pain medications (NSAIDs).

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,434 Previous Clinical Trials
2,447,960 Total Patients Enrolled
3 Trials studying Kidney Stones
320 Patients Enrolled for Kidney Stones
Coloplast A/SIndustry Sponsor
153 Previous Clinical Trials
14,611 Total Patients Enrolled
1 Trials studying Kidney Stones
224 Patients Enrolled for Kidney Stones
Ojas Shah, MDPrincipal Investigator - Professor of Urology
Morgan Stanley Children's Hospital, New York Presbyterian Hospital-Columbia Presbyterian Center, New York State Psychiatric Institute
Northwestern University Medical Sch (Medical School)
Ny University Medical Center (Residency)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have signed up to participate in this trial thus far?

"Affirmative. Clinicaltrials.gov information confirms the ongoing recruitment of 78 patients from 1 medical centre, which was first posted on June 29th 2021 and updated most recently on July 16th 2021."

Answered by AI

Has research been conducted on Fexofenadine Hcl 180Mg Tab prior to this trial?

"Presently, there are 5 clinical trials operating with Fexofenadine Hcl 180Mg Tab. Two of these studies have advanced to the third stage and 17 medical sites scattered over San Francisco, California are participating in them."

Answered by AI

Are there still available slots for volunteers in this clinical experiment?

"Indeed, clinicaltrials.gov is showing that this trial launched on June 29th 2021 and has recently been updated. 78 participants are needed to be enrolled from one site only."

Answered by AI

What is the intended purpose of this investigation?

"The primary evaluation metric of this trial is the alteration in USSQ body pain score, which will be assessed on three occasions: pre-surgery (baseline), one or two weeks post-operation and four to six weeks after stent removal. Secondary assessments include adverse drug reactions, duration of NSAID utilization, and quantity of narcotic consumption - all self-reported by patients."

Answered by AI

Does my profile match the requirements for participation in this investigation?

"The eligibility criteria for this clinical trial mandates that participants possess kidney stones and be between the ages of 18-80. A total of 78 patients are required to establish a valid sample size."

Answered by AI

Does the age criterion for this clinical research cap at eighty years old?

"The age-span for participation in this clinical trial is 18 to 80 years old. There are 7 studies available for participants under 18 and 80 studies accessible to individuals over 65."

Answered by AI

What risks might be associated with Fexofenadine Hcl 180Mg Tab?

"Taking into account the Phase 2 trial data, our team estimated Fexofenadine Hcl 180Mg Tab's safety at a moderate score of 2. This drug has some evidence backing its security profile but no efficacy studies to draw from."

Answered by AI
~2 spots leftby Jun 2024