Condition category
Injury, Occupational Diseases, Poisoning
Date applied
04/03/2013
Date assigned
19/03/2013
Last edited
19/03/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
A DHEP medicated plaster contains 180 mg of a diclofenac salt, named diclofenac epolamine or DHEP, and it allows a continuous release of the drug from the plaster during the application period. This plaster has been marketed by many years in Europe and USA for the local treatment of pain and inflammation of traumatic and rheumatic origin. Our goal was to demonstrate how well the DHEP plaster works for the treatment of minor soft tissue injuries in the Chinese population.

Who can participate?
Adult male and female patients (18-65 years) with a minor soft tissue injury, such as ankle or knee joint sprain, muscle strain or contusion, which has occurred within the last 72 hours.

What does the study involve?
Participants were randomly allocated to one of two groups. One group of patients applied two DHEP plasters per day, each for 12 hours, for 7 days. The other group applied a placebo (dummy) plaster instead. During the study the severity of pain was measured using an established scale. The safety was also assessed by blood and urinalysis at the beginning and at the end of the study.

What are the possible benefits and risks of participating?
The participants who received the DHEP plaster can expect an improvement of their pain symptoms. The most common side effects seen with DHEP plasters are skin reactions (including itching, inflamed skin, burning) at the site of treatment.

Where is the study run from?
From 10 medical centres in China, with Peking University First Hospital in Beijing as lead centre.

When is the study starting and how long is it expected to run for?
The study started in April 2010 and ended in November 2010 when the required number of 384 patients (192 for each group) was recruited and treated.

Who is funding the study?
IBSA Institut Biochimique (Switzerland)

Who is the main contact?
Dr Chunde Li
lichunde@medmail.com.cn

Trial website

Contact information

Type

Scientific

Primary contact

Dr Chunde Li

ORCID ID

Contact details

Department of Orthopaedics
First Hospital of Peking University Xicheng District
No.1 Dahongluochang Street
Beijing
100034
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

09RC-Fp14

Study information

Scientific title

A multicentre, randomised, double-blind, placebo-controlled confirmatory clinical trial of the efficacy and safety of diclofenac epolamine medicated plaster in the treatment of minor soft tissue injuries

Acronym

Study hypothesis

To evaluate the efficacy and safety of DHEP medicated plaster for the treatment of minor soft tissue injury when compared to placebo.

Ethics approval

Ethics Committee of Peking University First Hospital (China), 17 March 2010, Approval number: 2009L00819

Study design

Multicenter double-blind placebo-controlled randomized confirmatory phase III 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 use the contact details below to request a patient information sheet

Condition

Minor soft tissue injuries, such as ankle or knee joint sprains, muscle strains or contusions

Intervention

Patients were randomised to receive either
1. DHEP medicated plaster (Flector®, IBSA Institut Biochimique SA): twice daily (morning and evening, every 12 hours) for 7 days
2. Placebo plaster: twice daily (morning and evening, every 12 hours) for 7 days

Intervention type

Drug

Phase

Phase III

Drug names

Diclofenac epolamine

Primary outcome measures

Reduction in pain on movement (VAS score) at the end of treatment (Day 7), as com-pared to pre-treatment scores

Secondary outcome measures

1. Pain on movement day-by-day evaluation (VAS score)
2. Summed pain intensity difference (SPID)
3. Rescue medication consumption (paracetamol)
4. Overall treatment efficacy as judged by patient and Investigator
5. Compliance to treatment
6. Overall treatment tolerability as judged by patient and Investigator
7. Adverse events
8. Pre-/post-treatment changes in haematology, blood chemistry, urinalysis or ECG tests

Overall trial start date

01/04/2010

Overall trial end date

30/11/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Outpatients and emergency patients of both gender
2. Aged between 18 and 65 years
3. With a minor soft tissue injury occurred within the past 72 hours
4. With pain on movement greater than or equal to 50 mm on VAS

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

384

Participant exclusion criteria

1. Severe injuries requiring orthopaedic, surgical or physiotherapeutic treatment
2. Open skin lesion or any dermatological condition at treated site
3. Administration of any topical medication within the past 24 hours
4. Administration of OTC analgesic or NSAIDs within the past 36-48 hours
5. Administration of long-acting NSAIDs within the past 72 hours
6. Administration of narcotic analgesics within the past 7 days
7. Administration of systemic anti-inflammatory steroidal drugs within the past 60 days

Recruitment start date

01/04/2010

Recruitment end date

30/11/2010

Locations

Countries of recruitment

China

Trial participating centre

Department of Orthopaedics
Beijing
100034
China

Sponsor information

Organisation

Institut Biochimique SA (IBSA) (Switzerland)

Sponsor details

Via del Piano
Pambio-Noranco
6915
Switzerland
stefano.rovati@ibsa.ch

Sponsor type

Industry

Website

http://www.ibsa-international.com/

Funders

Funder type

Industry

Funder name

IBSA Institut Biochimique SA (Switzerland)

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