Efficacy Management and Adherence Evaluation of Diclofenac in the Treatment of Knee Osteoarthritis Pain

January 14, 2019 updated by: Peking University People's Hospital
To investigate the effect of dichloride on pain control of knee osteoarthritis and the relationship between pain relief and medicine adherence. To evaluate the pain relief rate of patients with different initial pain.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Xicheng District
      • Beijing, Xicheng District, China, 100044
        • Peking University People's Hospital

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

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • According to the OA diagnostic criteria of knee joint, the side with higher WOMAC score is defined as observing knee joint for patients with both knees conforming to OA diagnostic criteria.

    1. Repeated knee pain in the past month
    2. X-ray showed narrowing of articular space, subchondral sclerosis and/or cystic degeneration, and formation of osteophyte at articular margin.
    3. Joint fluid (> 2 times) is cool and sticky, WBC < 2000/ml
    4. Age over 40
    5. Morning stiffness less than 30 minutes
    6. Bone fricative (sensation) during exercise According to 1+2 or 1+3+5+6 or 1+4+5+6, OA of knee joint can be diagnosed.
    7. The informed consent has been signed

Exclusion Criteria:

  • (1) Joint pain caused by other causes (infection, hip, lumbar and other diseases) (2) Secondary arthritis (rheumatoid arthritis, ankylosing spondylitis, etc.) (3) Severe internal medical complications and other inability to participate in the research (4) Pain in other parts exceeds joint pain (5) Contraindications to diclofenac use: active peptic ulcer/allergy/induced asthma (6) Assessment may not complete 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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adherence
Time Frame: 6-8 weeks
We will calculate adherence with medication use
6-8 weeks
pain relief rate
Time Frame: 6-8 weeks
We will calculate the pain relief rate on all participants
6-8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
womac score
Time Frame: 6-8 weeks
We will calculate the womac score on all participants
6-8 weeks

Collaborators and Investigators

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

Sponsor

Peking University People's Hospital

Investigators

  • Study Chair: Jianhao Lin, M.D., Peking University People's Hospital
  • Study Director: Yudian Qiu, M.D., Peking University People's 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 (Anticipated)

January 15, 2019

Primary Completion (Anticipated)

March 10, 2019

Study Completion (Anticipated)

March 15, 2019

Study Registration Dates

First Submitted

January 14, 2019

First Submitted That Met QC Criteria

January 14, 2019

First Posted (Actual)

January 16, 2019

Study Record Updates

Last Update Posted (Actual)

January 16, 2019

Last Update Submitted That Met QC Criteria

January 14, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PekingUPHmed

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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 To Investigate the Effect of Diclofenac on Pain Control of Knee Osteoarthritis and the Relationship Between Pain Relief and Medicine Adherence

Clinical Trials on regular follow-up

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe