Urinary CalculusPhase 4NCT01010048
Compare the Therapeutic Effect Treated With Tamsulosin and Progesterone After ESWL( Extra Corporeal Shock Wave Lithotripsy) in Urinary Calculus
A Phase 4 study testing progesterone,tamsulosin,propantheline Bromide and nifedipine in people with Urinary Calculus, run by Chongqing Medical University at 1 site in China.
Trial summary
The purpose of this study is to compare the stone clearance rate treated with different drugs after ESWL in urinary calculus,These drugs are often used in urinary calculus,such as progesterone,tamsulosin,propantheline Bromide and nifedipine.In these study the investigators want to investigate different effect of these… Read more about this study
- Who is it for?
- Ages 18 to 68 yearsHealthy volunteers can take part
- Conditions the study is for
- Urinary Calculus
- What is being tested?
- progesterone,tamsulosin,propantheline Bromide and nifedipine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Oct 2009to Dec 2010
- 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 to 68 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- From 18 years old to 68 years old,
- urinary calculus could be treated by ESWL,
- the calculus size is from 4-25mm
Who cannot join
- Less than 18 years old or more than 68 years old,
- the calculus size is from Less than4 or larger than 25mm
Trial locations and contacts
1 site in 1 country.
Yunfeng He, Doctor contact
Xiaohou Wu, Doctor contact
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital, ChongQing medical University
Chongqing, Chongqing Municipality, 400016
Yunfeng He, Doctor, 86-23-89011121
Xiaohou Wu, Doctor, 86-23-89011122
About this study
Official title: the Therapeutic Effect Treated With Tamsulosin After ESWL in Urinary Calculus
The purpose of this study is to compare the stone clearance rate treated with different drugs after ESWL in urinary calculus,These drugs are often used in urinary calculus,such as progesterone,tamsulosin,propantheline Bromide and nifedipine.In these study the investigators want to investigate different effect of these drugs use to treat urinary calculus after ESWL.
Read the detailed description
There is 4 groups in these investigation, group1 urinary calculus treated with ESWL only ,group2 urinary calculus treated with ESWL and tamsulosin,group3 urinary calculus treated with ESWL and progesterone,group4 urinary calculus treated with ESWL ,propantheline Bromide and nifedipine.We want to investigate which one is better or not in urinary calculus treated with ESWL .
- Conditions
- Urinary Calculus
- Being tested
- progesterone,tamsulosin,propantheline Bromide and nifedipine
- Keywords
- ESWL, urinary calculus, drugs treat
- Medical subject headings
- Urinary Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
progesterone,tamsulosin,propantheline Bromide and nifedipineDrug
clearance rate of stone
| Study group | Role | What they receive |
|---|---|---|
| progesterone,tamsulosin,propantheline Bromide and nifedipine | Experimental | different effect of these drugs use to treat urinary calculus after ESWL Receives: Drug: progesterone,tamsulosin,propantheline Bromide and nifedipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
different effect of these drugs use to treat urinary calculus after ESWL
Measured: 2weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionOct 2009 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary CalculusStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing Medical University
- Sponsor type
- University, hospital or other
- Investigators
- xiaohou wu, doctor, Study chair, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01010048
- Sponsor's protocol ID
- CQMU
- Status last verified
- Nov 2009
- First submitted
- 6 Nov 2009
- Last updated
- 13 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Therapeutic Effect Treated With Tamsulosin After ESWL in Urinary Calculus
- ClinicalTrials.gov ID
- NCT01010048
- Acronym / sponsor ID
- CQMU
- Conditions
- Urinary Calculus
- Keywords
- ESWL, urinary calculus, drugs treat
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Oct 2009 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 9 Nov 2009 (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.
The purpose of this study is to compare the stone clearance rate treated with different drugs after ESWL in urinary calculus,These drugs are often used in urinary calculus,such as progesterone,tamsulosin,propantheline Bromide and nifedipine.In these study the investigators want to investigate different effect of these drugs use to treat urinary calculus after ESWL.
Detailed description
There is 4 groups in these investigation, group1 urinary calculus treated with ESWL only ,group2 urinary calculus treated with ESWL and tamsulosin,group3 urinary calculus treated with ESWL and progesterone,group4 urinary calculus treated with ESWL ,propantheline Bromide and nifedipine.We want to investigate which one is better or not in urinary calculus treated with ESWL .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| progesterone,tamsulosin,propantheline Bromide and nifedipine | Experimental | Drug: progesterone,tamsulosin,propantheline Bromide and nifedipinedifferent effect of these drugs use to treat urinary calculus after ESWL |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- From 18 years old to 68 years old,
- urinary calculus could be treated by ESWL,
- the calculus size is from 4-25mm
Key exclusion criteria (2 listed)
- Less than 18 years old or more than 68 years old,
- the calculus size is from Less than4 or larger than 25mm
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 |
|---|---|---|
| progesterone,tamsulosin,propantheline Bromide and nifedipineclearance rate of stone | Drug | progesterone,tamsulosin,propantheline Bromide and nifedipine |
Primary outcome
different effect of these drugs use to treat urinary calculus after ESWL
Time frame: 2weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2009.
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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.
Yunfeng He, Doctor contact
Xiaohou Wu, Doctor contact
xiaohou wu, doctor study chair
First Affiliated Hospital of Chongqing Medical University
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 progesterone,tamsulosin,propantheline Bromide and nifedipine in people with Urinary Calculus, run by Chongqing Medical University at 1 site in China.
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 2 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 13 Nov 2009. 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 China. 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. 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 Yunfeng He, Doctor (86-23-89011121), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
different effect of these drugs use to treat urinary calculus after ESWL (time frame: 2weeks). 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 13 Nov 2009.