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

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ClinicalTrials.gov Identifier: NCT01167062
Recruitment Status : Unknown
Verified June 2010 by ChaingMai University.
Recruitment status was:  Recruiting
First Posted : July 22, 2010
Last Update Posted : July 22, 2010
Sponsor:
Information provided by:

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  (Clinical Trial)
Estimated 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 : June 2010
Estimated Primary Completion Date : April 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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. [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Number of diclofenac injection used [ Time Frame: 28 days ]
  2. Rate of occurrence of adverse events [ Time Frame: 28 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01167062


Contacts
Contact: Bannakij Lojanapiwat, M.D. 66-53-945532 blojanap@mail.med.cmu.ac.th

Locations
Thailand
Maharat Nakhon Chiangmai Hospital Recruiting
Muang, Chiangmai, Thailand, 50200
Contact: Bannakij Lojanapiwat, M.D.    66-53-945532    blojanap@mail.med.cmu.ac.th   
Principal Investigator: Bannakij Lojanapiwat, M.D.         
Sponsors and Collaborators
ChaingMai University
More Information

Responsible Party: Bannakij Lojanapiwat M.D, Chiang Mai University
ClinicalTrials.gov Identifier: NCT01167062     History of Changes
Other Study ID Numbers: TAM040-0109
First Posted: July 22, 2010    Key Record Dates
Last Update Posted: July 22, 2010
Last Verified: June 2010

Additional relevant MeSH terms:
Calculi
Ureteral Calculi
Ureterolithiasis
Pathological Conditions, Anatomical
Ureteral Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Tamsulosin
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents