Ureteral CalculiPhase 4NCT01167062
Efficacy of Tamsulosin Oral-controlled Absorption System (OCAS) in the Treatment of Distal Ureteral Stones
A Phase 4 study testing Tamsulosin Hydrochloride OCAS 0.4 mg in people with Ureteral Calculi, run by Chiang Mai University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ureteral Calculi
- What is being tested?
- Tamsulosin Hydrochloride OCAS 0.4 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteThailand
- Study dates
- Jun 2010to Apr 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Maharat Nakhon Chiangmai Hospital
Muang, Chiangmai, 50200
Bannakij Lojanapiwat, M.D., 66-53-945532, blojanap@mail.med.cmu.ac.th
Bannakij Lojanapiwat, M.D.
About this study
Official title: 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.
Read the 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
- Conditions
- Ureteral Calculi
- Being tested
- Tamsulosin Hydrochloride OCAS 0.4 mg, Placebo
- Medical subject headings
- Ureteral Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tamsulosin Hydrochloride OCAS 0.4 mgDrug
One tablet OD for a maximum of 28 days
PlaceboOther
One tablet OD for a maximum of 28 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
| Tamsulosin Hydrochloride OCAS 0.4 mg | Experimental | Not described Receives: Drug: Tamsulosin Hydrochloride OCAS 0.4 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone expulsion rate and time.
Measured: 28 days
Secondary outcomes (2)
Number of diclofenac injection used
Measured: 28 days
Rate of occurrence of adverse events
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionApr 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteral CalculiStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01167062
- Sponsor's protocol ID
- TAM040-0109
- Status last verified
- Jun 2010
- First submitted
- 16 Jul 2010
- Last updated
- 22 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Tamsulosin OCAS in the Conjunctive Medical Treatment of Distal Ureteral Stones.A Randomized, Double-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT01167062
- Acronym / sponsor ID
- TAM040-0109
- Conditions
- Ureteral Calculi
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Apr 2011 (estimated)
- First posted
- 22 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebo |
| Tamsulosin Hydrochloride OCAS 0.4 mg | Experimental | Drug: Tamsulosin Hydrochloride OCAS 0.4 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tamsulosin Hydrochloride OCAS 0.4 mgOne tablet OD for a maximum of 28 days | Drug | Tamsulosin Hydrochloride OCAS 0.4 mg |
| PlaceboOne tablet OD for a maximum of 28 days | Other | Placebo |
Primary outcome
Stone expulsion rate and time.
Time frame: 28 days
2 secondary outcomes
Number of diclofenac injection used
Time frame: 28 days
Rate of occurrence of adverse events
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tamsulosin Hydrochloride OCAS 0.4 mg in people with Ureteral Calculi, run by Chiang Mai University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bannakij Lojanapiwat, M.D. (66-53-945532, blojanap@mail.med.cmu.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone expulsion rate and time. (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2010.