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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:
ChaingMai University

Tracking Information
First Submitted Date  ICMJE July 16, 2010
First Posted Date  ICMJE July 22, 2010
Last Update Posted Date July 22, 2010
Study Start Date  ICMJE June 2010
Estimated Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 21, 2010)
Stone expulsion rate and time. [ Time Frame: 28 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2010)
  • Number of diclofenac injection used [ Time Frame: 28 days ]
  • Rate of occurrence of adverse events [ Time Frame: 28 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Tamsulosin Oral-controlled Absorption System (OCAS) in the Treatment of Distal Ureteral Stones
Official Title  ICMJE Efficacy of Tamsulosin OCAS in the Conjunctive Medical Treatment of Distal Ureteral Stones.A Randomized, Double-blind, Placebo-controlled Study
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Ureteral Calculi
Intervention  ICMJE
  • Drug: Tamsulosin Hydrochloride OCAS 0.4 mg
    One tablet OD for a maximum of 28 days
  • Other: Placebo
    One tablet OD for a maximum of 28 days
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
  • Experimental: Tamsulosin Hydrochloride OCAS 0.4 mg
    Intervention: Drug: Tamsulosin Hydrochloride OCAS 0.4 mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 21, 2010)
120
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01167062
Other Study ID Numbers  ICMJE TAM040-0109
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bannakij Lojanapiwat M.D, Chiang Mai University
Study Sponsor  ICMJE ChaingMai University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account ChaingMai University
Verification Date June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP