A Study on the Effection of Potassium Citrate Extended-release Tablets on Urolithiasis Formation or Recurrence

January 31, 2018 updated by: Dawnrays Pharmaceutical (Holdings) Limited

A Randomized, Blank Controlled, Multicenter Clinical Trial of the Effection of Potassium Citrate Extended-release Tablets on Urolithiasis Formation or Recurrence

Assess the efficacy and safety of potassium citrate extended-release tablets on Urolithiasis formation or recurrence.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study takes "Rate of stone recurrence" as primary outcome measure, by random, blank control, and multicenter clinical trial design method, assess the efficacy and safety of potassium citrate extended-release tablets on Urolithiasis formation or recurrence, provide evidence for drug re-registration, and observe its efficacy on Urinary calculi such as renal tubular acidosis with calcium stone, and uric acid stones with or without calcium stone, urinary tract stone of effectiveness.

Study Type

Interventional

Enrollment (Anticipated)

2001

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

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • The Fifth Affiliated Hospital of Guangzhou Medical University
        • Contact:
        • Principal Investigator:
          • Yongzhong HE
        • Sub-Investigator:
          • Dehui LAI
    • Henan
      • Zhengzhou, Henan, China
        • Recruiting
        • The Second Affiliated Hospital of Zhengzhou University
        • Contact:
        • Principal Investigator:
          • Changbao XU
        • Sub-Investigator:
          • Changwei LIU
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
        • Principal Investigator:
          • Zhangqun YE, M.D.
        • Sub-Investigator:
          • Xiaolin GUO, M.D.
      • Wuhan, Hubei, China
        • Active, not recruiting
        • Wuhan No.1 Hospital（Wuhan Integrated TCM & Western Medicine Hospital）
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai Ninth People's Hospital,Shanghai Jiaotong University School of Medicine
        • Contact:
        • Principal Investigator:
          • Zhong WANG
        • Sub-Investigator:
          • Mingxi XU
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Zhejiang Xiaoshan Hospital
        • Contact:
        • Principal Investigator:
          • Yi FAN
        • Sub-Investigator:
          • Xing WANG

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

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with upper urinary tract calculi surgery and/or ESWL within 3 months；
  • Stone free or had residual stone fragments with a less than 4 mm diamete；
  • 18-70 years of age; the gender is not limited；
  • Agree to take effective contraceptive measures during the study period, and female of childbearing age whose pregnancy test is negative；
  • Subjects with no mental illness and language dysfunction, can understand the situation of the study and have signed informed consent.

Exclusion Criteria:

  • Patients with infectious stones, medical stones and urinary tract obstruction；
  • Patients with hyperkalemia (K+>5.5mmol/L) (or patients with factors or disease that can cause hyperkalemia), because the further increase in blood potassium can lead to cardiac arrest. These factors include disease or strenuous exercise, chronic renal failure, uncontrolled diabetes, acute dehydration, excessive, adrenal insufficiency, extensive tissue failure. Patients who takes potassium sparing diuretics (such as triamterene, spironolactone, amiloride)；
  • Patients with gastrointestinal disorders, such as peptic ulcer, severe vomiting, diarrhea, delayed gastric emptying, intestinal obstruction, etc.；
  • Combined with cardiovascular, liver, kidney, hematopoietic system, such as severe primary disease, or known to affect the survival of serious diseases (such as cancer or AIDS), or patients with with disabilities mentally or legally；
  • Patients with renal insufficiency (1.2 times the upper limit of the normal value of serum creatinine and urea nitrogen)；
  • The recent (within 6 months) with family planners；
  • Allergic to this product；
  • To participate in other clinical trials in the past three months.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
Potassium Citrate Extended-release Tablets
Drug: Potassium Citrate Extended-release Tablets
Daily 3.24g, Po ,Tid, each 1.08g/tablets
Other Names:
  • Juyuansuanjia Huanshi Pian
No Intervention: Blank control group
Subjects do not take the investigational product

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of Urolithiasis recurrence
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Time of stone recurrence
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
The changes of urine citric acid content compared with baseline
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
The changes of Urine pH value compared with baseline
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dawnrays Pharmaceutical (Holdings) Limited

Investigators

  • Principal Investigator: Zhangqun YE, M.D., Tongji Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2016

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

December 13, 2016

First Submitted That Met QC Criteria

December 29, 2016

First Posted (Estimate)

January 2, 2017

Study Record Updates

Last Update Posted (Actual)

February 1, 2018

Last Update Submitted That Met QC Criteria

January 31, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAWNRAYS101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

Clinical Trials on Urolithiasis

Clinical Trials on Potassium Citrate Extended-release Tablets

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Switzerland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe