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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01010048
Other study ID # CQMU
Secondary ID
Status Recruiting
Phase Phase 4
First received November 6, 2009
Last updated November 12, 2009
Start date October 2009
Est. completion date December 2010

Study information

Verified date November 2009
Source Chongqing Medical University
Contact Yunfeng He, Doctor
Phone 86-23-89011121
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical 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 drugs use to treat urinary calculus after ESWL.


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 .


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date December 2010
Est. primary completion date October 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 68 Years
Eligibility Inclusion Criteria:

- From 18 years old to 68 years old,

- urinary calculus could be treated by ESWL,

- the calculus size is from 4-25mm

Exclusion Criteria:

- Less than 18 years old or more than 68 years old,

- the calculus size is from Less than4 or larger than 25mm

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
progesterone,tamsulosin,propantheline Bromide and nifedipine
clearance rate of stone

Locations

Country Name City State
China The First Affiliated Hospital, ChongQing medical University ChongQing Chongqing

Sponsors (1)

Lead Sponsor Collaborator
Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary different effect of these drugs use to treat urinary calculus after ESWL 2weeks Yes
See also
  Status Clinical Trial Phase
Completed NCT01539265 - A Dose-finding Study of Silodosin in Patients With Urinary Calculi Phase 2