Condition category
Musculoskeletal Diseases
Date applied
15/11/2012
Date assigned
13/12/2012
Last edited
15/06/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Knee arthrosis occurs when the protective layer around the knee is damaged due to wear and tear, causing the bones to rub against each other. This causes pain and stiffness. There are a number of different treatment methods, such as taking anti-inflammatory (swelling) medications for pain relief. The medication can come in an ointment or in a tablet to be taken by mouth. However, taking tabulets by mouth can injury the digestive area, liver and kidneys. Using ointment may be a better option. The aim of this study is to compare the results of taking an anti-inflammatory medication called Loxoprofen Sodium Cataplasm as either an ointment or a tablet for the treatment of knee osteoarthritis.

Who can participate?
Patients aged between 18 and 80 years Knee osteoarthritis

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive the treatment as an ointment that they apply once a day and a placebo (dummy) tablet three times a day. Those in the second group receive a placebo ointment and the medication as a tablet that is taken three times a day. This is done for four weeks. Participants are followed up to see if their symptoms have improved.

What are the possible benefits and risks of participating?
After you participate this study, you can get better treatment for the knee osteoarthritis. At the same time, there exist some risks. The study drug may induce the drug adverse events. These drug adverse events may occur on you or not.

Where is the study run from?
Peking University and People’s Hospital (China)

When is study starting and how long is it expected to run for?
July 2010 to February 2012

Who is funding the study?
Lead Chemical Co. Ltd (Japan)

Who is the main contact?
Professor Rong Mu
murongster@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Prof Zhan-guo Li

ORCID ID

Contact details

People's Hospital
Peking University
11 South Xizhimen Street
Bei Jing
100044
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

YXCS-01-LOX

Study information

Scientific title

A randomized, controlled, double blind, double dummy clinical trial to evaluate the safety and efficacy of Loxoprofen Sodium Cataplasm Ointment (Loxonin®PAP100mg) against knee osteoarthritis

Acronym

SELSOAKO

Study hypothesis

There will be non-inferiority between Loxoprofen Sodium Cataplasm Ointment and its tablet fomuration for the treatment of knee osteoarthritis.

Ethics approval

Central Ethic Committee of Peking University People's Hospital, 27 July 2010 ref: 35

Study design

Randomized controlled double blind double dummy study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please contact murongster@gmail.com to request a patient information sheet

Condition

Knee osteoarthritis

Intervention

Study group: Loxoprofen Sodium Cataplasm ointment one time each day, one patch each time (100 mg) + placebo tablet 3 times a day, 1 tablet each time (60 mg)

Control group: Placebo Cataplasm ointment one time each day, one patch each time (100 mg) + Loxoprofen Sodium tablet 3 times a day, 1 tablet each time (60 mg)

Administration duration is 4 weeks, and the prescription is changed for every 2 weeks.

Intervention type

Drug

Phase

Not Specified

Drug names

Loxoprofen

Primary outcome measures

Total effective rates after 4 weeks treatment
1. Apparently improved
2. Improved
3. Slightly improved
4. Unchanged
5. Slightly aggravated
6. Aggravated
7. Significantly aggravated

Secondary outcome measures

Effective rates against different symptoms

Overall trial start date

27/07/2010

Overall trial end date

10/02/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age: > 18 years, < 80 years
2. Sex: unrestricted
3. Patients conforming to clinical diagnostic criteria
4. Patients agree to participate this trial and sign informed content form after completely understanding the contents of the clinical trial

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

160

Participant exclusion criteria

1. Patients with digestive ulcers
2. Patients with bronchial asthma
3. Patients with serious cardiac diseases, hepatic diseases (ALT, AST are equal or bigger than 2.5 times of upper limit), renal diseases (creatinine is equal or bigger than 1.5 times of upper limit), hematologic disease, diabetes, mental diseases, and other serious complications
4. Pregnant women, lactating women, patients with pregnancy potential, and patients who want to be pregnant during the clinical trial
5. Patients with drug hypersensitivity (aspirin asthma, hypersensitive to loxoprofen sodium or other drugs)
6. Patients with lesions, poor skin conditions on pasting site, or with cutaneous anaphylaxis (dermatitis due to external agent or patients with dermatitis)
7. Patients combining other rheumatic diseases
8. Patients who need steroid drugs or other non-steroid analgesics which may interfere the therapeutic method in this clinical trial
9. Patients participating any clinical trials on investigational drug or marketing drug within 3 months before inclusion or during clinical trial
10. Other patients judged to be inappropriate for this clinical trial by the investigator

Recruitment start date

27/07/2010

Recruitment end date

10/02/2012

Locations

Countries of recruitment

China

Trial participating centre

People's Hospital
Bei Jing
100044
China

Sponsor information

Organisation

Lead Chemical Co. Ltd (Japan)

Sponsor details

77-3 Himata
Toyama
930-0912
Japan

Sponsor type

Industry

Website

http://www.lead-chemical.co.jp

Funders

Funder type

Industry

Funder name

Lead Chemical Co. Ltd (Japan)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

15/06/2017: Plain English summary added.