Efficacy of Tamsulosin Oral-controlled Absorption System (OCAS) in the Treatment of Distal Ureteral Stones

Chiang Mai University

Status and phase: Unknown; Phase 4

Conditions: Ureteral Calculi

Treatments: Drug: Tamsulosin Hydrochloride OCAS 0.4 mg; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01167062

TAM040-0109

Details and patient eligibility

About

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.

Full description

• patient will be randomized to receive placebo or Tamsulosin OCAS 0.4 mg 1 tablet OD for a maximum of 28 days or until the ureteral stone is passed and sodium diclofenac 50 mg twice a day, for 10 days.
• All patients will receive 75 mg sodium diclofenac via intramuscular on demand

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Other: Placebo

Tamsulosin Hydrochloride OCAS 0.4 mg

Experimental group

Treatment:

Drug: Tamsulosin Hydrochloride OCAS 0.4 mg