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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by ChaingMai University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
ChaingMai University
ClinicalTrials.gov Identifier:
NCT01167062
First received: July 16, 2010
Last updated: July 21, 2010
Last verified: June 2010
  Purpose

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 Intervention Phase
Ureteral Calculi
Drug: Tamsulosin Hydrochloride OCAS 0.4 mg
Other: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by ChaingMai University:

Primary Outcome Measures:
  • Stone expulsion rate and time. [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of diclofenac injection used [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Rate of occurrence of adverse events [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: June 2010
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Bannakij Lojanapiwat M.D, Chiang Mai University
ClinicalTrials.gov Identifier: NCT01167062     History of Changes
Other Study ID Numbers: TAM040-0109
Study First Received: July 16, 2010
Last Updated: July 21, 2010
Health Authority: Thailand: Ethical Committee

Additional relevant MeSH terms:
Ureteral Diseases
Calculi
Ureteral Calculi
Ureterolithiasis
Pathological Conditions, Anatomical
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
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 27, 2014