Clinical trial to evaluate the safety and efficacy of a diclofenac epolamine (DHEP) plaster in minor soft tissue injuries

ISRCTN	ISRCTN42875603
DOI	https://doi.org/10.1186/ISRCTN42875603
Secondary identifying numbers	09RC-Fp14

Submission date: 04/03/2013
Registration date: 19/03/2013
Last edited: 19/03/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Chunde Li
Scientific

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

Study information

Study design	Multicenter double-blind placebo-controlled randomized confirmatory phase III study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study objectives	To evaluate the efficacy and safety of DHEP medicated plaster for the treatment of minor soft tissue injury when compared to placebo.
Ethics approval(s)	Ethics Committee of Peking University First Hospital (China), 17 March 2010, Approval number: 2009L00819
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Phase III
Drug / device / biological / vaccine name(s)	Diclofenac epolamine
Primary outcome measure	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 study start date	01/04/2010
Completion date	30/11/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	384
Key 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
Key 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
Date of first enrolment	01/04/2010
Date of final enrolment	30/11/2010

Locations

Countries of recruitment

China

Study participating centre

Department of Orthopaedics

Beijing
100034
China

Sponsor information

Institut Biochimique SA (IBSA) (Switzerland)
Industry

Via del Piano
Pambio-Noranco
6915
Switzerland

Email	stefano.rovati@ibsa.ch
Website	http://www.ibsa-international.com/
"ROR"	https://ror.org/051tj3a26

Funders

Funder type

Industry

IBSA Institut Biochimique SA (Switzerland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan