- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01167062
Efficacy of Tamsulosin Oral-controlled Absorption System (OCAS) in the Treatment of Distal Ureteral Stones
July 21, 2010 updated by: ChaingMai University
Efficacy of Tamsulosin OCAS in the Conjunctive Medical Treatment of Distal Ureteral Stones.A Randomized, Double-blind, Placebo-controlled Study
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Anticipated)
120
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Bannakij Lojanapiwat, M.D.
- Phone Number: 66-53-945532
- Email: blojanap@mail.med.cmu.ac.th
Study Locations
-
-
Chiangmai
-
Muang, Chiangmai, Thailand, 50200
- Recruiting
- Maharat Nakhon Chiangmai Hospital
-
Contact:
- Bannakij Lojanapiwat, M.D.
- Phone Number: 66-53-945532
- Email: blojanap@mail.med.cmu.ac.th
-
Principal Investigator:
- Bannakij Lojanapiwat, M.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
One tablet OD for a maximum of 28 days
|
Experimental: Tamsulosin Hydrochloride OCAS 0.4 mg
|
One tablet OD for a maximum of 28 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Stone expulsion rate and time.
Time Frame: 28 days
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of diclofenac injection used
Time Frame: 28 days
|
28 days
|
Rate of occurrence of adverse events
Time Frame: 28 days
|
28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (Anticipated)
April 1, 2011
Study Registration Dates
First Submitted
July 16, 2010
First Submitted That Met QC Criteria
July 21, 2010
First Posted (Estimate)
July 22, 2010
Study Record Updates
Last Update Posted (Estimate)
July 22, 2010
Last Update Submitted That Met QC Criteria
July 21, 2010
Last Verified
June 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urologic Diseases
- Pathological Conditions, Anatomical
- Ureteral Diseases
- Urolithiasis
- Urinary Calculi
- Calculi
- Ureteral Calculi
- Ureterolithiasis
- Physiological Effects of Drugs
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Urological Agents
- Adrenergic alpha-1 Receptor Antagonists
- Adrenergic alpha-Antagonists
- Tamsulosin
Other Study ID Numbers
- TAM040-0109
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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