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

• Sponsor: ChaingMai University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01167062
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ureteral Calculi	Drug: Tamsulosin Hydrochloride OCAS 0.4 mg; Other: Placebo	Phase 4

Detailed 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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Efficacy of Tamsulosin OCAS in the Conjunctive Medical Treatment of Distal Ureteral Stones.A Randomized, Double-blind, Placebo-controlled Study
• Study Start Date: Jun 1, 2010
• Anticipated Primary Completion Date: Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo	Other: Placebo; One tablet OD for a maximum of 28 days
Experimental: Tamsulosin Hydrochloride OCAS 0.4 mg	Drug: Tamsulosin Hydrochloride OCAS 0.4 mg; One tablet OD for a maximum of 28 days

Outcome Measures

Primary Outcome Measures

1. Stone expulsion rate and time. [28 days]

Secondary Outcome Measures

1. Number of diclofenac injection used [28 days]

2. Rate of occurrence of adverse events [28 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maharat Nakhon Chiangmai Hospital	Muang	Chiangmai	Thailand	50200

Sponsors and Collaborators

• ChaingMai University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01167062
• Other Study ID Numbers: TAM040-0109
• First Posted: Jul 22, 2010
• Last Update Posted: Jul 22, 2010
• Last Verified: Jun 1, 2010

• Additional relevant MeSH terms: Ureteral Calculi; Ureterolithiasis; Calculi; Tamsulosin

Study Results

No Results Posted as of Jul 22, 2010