Ureteral Calculi Clinical Trial
Official title:
Efficacy of Tamsulosin OCAS in the Conjunctive Medical Treatment of Distal Ureteral Stones.A Randomized, Double-blind, Placebo-controlled Study
NCT number | NCT01167062 |
Other study ID # | TAM040-0109 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 4 |
First received | July 16, 2010 |
Last updated | July 21, 2010 |
Start date | June 2010 |
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.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | |
Est. primary completion date | April 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Thailand | Maharat Nakhon Chiangmai Hospital | Muang | Chiangmai |
Lead Sponsor | Collaborator |
---|---|
ChaingMai University |
Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Stone expulsion rate and time. | 28 days | No | |
Secondary | Number of diclofenac injection used | 28 days | No | |
Secondary | Rate of occurrence of adverse events | 28 days | Yes |
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