Plain English Summary

Lay summary under review 2

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

Editorial Notes