Efficacy of Tamsulosin Oral-controlled Absorption System (OCAS) in the Treatment of Distal Ureteral Stones
Efficacy of Tamsulosin OCAS in the Conjunctive Medical Treatment of Distal Ureteral Stones.A Randomized, Double-blind, Placebo-controlled Study
1 other identifier
interventional
120
1 country
1
Brief Summary
This is a randomized double blind placebo-controlled study that will assess the efficacy of Tamsulosin oral-controlled absorption system (OCAS) 0.4 mg in the conjunctive medical treatment of distal ureteral stones with a size of 4-10 mm compared to placebo in control group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 16, 2010
CompletedFirst Posted
Study publicly available on registry
July 22, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedJuly 22, 2010
June 1, 2010
10 months
July 16, 2010
July 21, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Stone expulsion rate and time.
28 days
Secondary Outcomes (2)
Number of diclofenac injection used
28 days
Rate of occurrence of adverse events
28 days
Study Arms (2)
Placebo
PLACEBO COMPARATORTamsulosin Hydrochloride OCAS 0.4 mg
EXPERIMENTALInterventions
One tablet OD for a maximum of 28 days
Eligibility Criteria
You may qualify if:
- Male or female patient aged =\> 18 years.
- Patients who have distal ureteral stones with a size of 4-10 mm
- Written informed consent has been obtained.
You may not qualify if:
- Patients with history of ureteral surgery
- Patients with urinary tract infection
- Patient with diabetes and peptic ulcer
- Patient with renal dysfunction (elevated of serum creatinine level)
- Patients with severe hydronephrosis
- Patients with history of passing stones
- Pregnancy
- Patients who desire to withdraw from the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maharat Nakhon Chiangmai Hospital
Muang, Chiangmai, 50200, Thailand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 16, 2010
First Posted
July 22, 2010
Study Start
June 1, 2010
Primary Completion
April 1, 2011
Last Updated
July 22, 2010
Record last verified: 2010-06