Soft Tissue InjuriesNCT03362216
Clinical Efficacy and Safety of Compound Methyl Salicylate Liniment
A study testing Compound Methyl Salicylate Liniment and Diclofenac Sodium Liniment in people with Soft Tissue Injuries, run by Peking University People's Hospital.
Trial summary
This clinical trial program was established according to the ethical principles of the Helsinki declaration and the GCP guiding principle, and a randomized grouping method was used to evaluate the efficacy and safety of Compound Methyl Salicylate Liniment in the treatment of acute and chronic soft tissue pain with a… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Soft Tissue Injuries
- What is being tested?
- Compound Methyl Salicylate Liniment and Diclofenac Sodium Liniment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- No sites listed yet
- Study dates
- 7 Apr 2009to 12 Jun 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with various causes of acute and chronic soft tissue
- Local symptoms and signs include pain, swelling, bruising, tenderness, joint dysfunction; X-ray showed no fracture, dislocation, bone tumors and bone metabolism and open injury.
Who cannot join
- Patients who do not belong to the scope of drug use
- Muscle, tendon, ligament and other soft tissue have broken completely
- Accompanied by skin damage or fracture, joint dislocation, bone tumor and metabolic bone disease local tissue damage
- Use of other drugs or therapies for the treatment of acute and chronic soft tissue pain after trauma
- Difficult to evaluate the effectiveness and safety of new drugs
- Severe hypertension, severe heart and lung dysfunction, severe arrhythmia, liver, kidney, hematopoietic system and other serious primary diseases, mental patients
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- Pregnant women, lactating women
- Allergic constitution and allergic to the known components of the drug
- Participated in other clinical trials in the past month
- Use similar analgesics within a week
- Other researchers considered inappropriate patients to participate in the trial
About this study
Official title: Clinical Efficacy and Safety of Compound Methyl Salicylate Liniment in the Treatment of Acute and Chronic Soft Tissue Pain：a Multicenter, Randomized, Positive Controlled Clinical Trial
This clinical trial program was established according to the ethical principles of the Helsinki declaration and the GCP guiding principle, and a randomized grouping method was used to evaluate the efficacy and safety of Compound Methyl Salicylate Liniment in the treatment of acute and chronic soft tissue pain with a positive control drug, named Diclofenac Sodium Liniment.
Read the detailed description
This study is a randomized, double-blind, parallel controlled multicenter clinical trial for evaluate the efficacy and safety of Compound Methyl Salicylate Liniment in the treatment of acute and chronic soft tissue pain with a positive control drug, named Diclofenac Sodium Liniment. A total of 216 participants with acute or chronic tissue pain participated in this clinical trial. The clinical trial cases were equally allocated to each research center, and each center had 30-35 cases. The proportion of patients with acute soft tissue pain and chronic soft tissue pain was 1:1, and the proportion of the experimental group and the control group was 1:1.The observation index include self pain scale record, tenderness scale and swelling, the evaluation period was 7 days.
The statistical analysis plan is prepared by the unit responsible for the statistics, and is prepared before the formal analysis of the data, and is discussed and identified at the blind audit meeting with the major researchers. Statistical analysis will use SAS8.2 statistical analysis software for data processing, and other statistical analysis plan to make detailed provisions. All the statistical tests were two-sided, and the value of P was less than or equal to 0.05, which would be considered statistically significant. Measurement data use case number, mean, standard deviation, minimum, maximum, median and four sub spacing description, counting data and grade data use case number, percentage description.
- Conditions
- Soft Tissue Injuries
- Being tested
- Compound Methyl Salicylate Liniment, Diclofenac Sodium Liniment
- Keywords
- soft tissue, pain
- Medical subject headings
- Soft Tissue Injuries, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compound Methyl Salicylate LinimentDrug
Compound Methyl Salicylate Liniment, apply to the affected area, 3 times a day.Course of treatment: 7 days
Diclofenac Sodium LinimentDrug
Diclofenac Sodium Liniment, apply to the affected area, 3 times a day. Course of treatment: 7 days
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Treated with Compound Methyl Salicylate Liniment group Receives: Drug: Compound Methyl Salicylate Liniment |
| Control group | Active comparator | Treated with Diclofenac Sodium Liniment group Receives: Drug: Diclofenac Sodium Liniment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Main observation index
Self pain scale record (VAS). A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.Operationally a VAS is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end, the patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks, the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain.
Measured: 7 days
Secondary outcomes (1)
Secondary observation index
Record of tenderness scale(VAS), Swelling. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. Operationally a VAS is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end, the patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks, the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start7 Apr 2009
- Primary completion22 May 2009
- Study completion12 Jun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue InjuriesStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, baoguojiang, Peking University People's Hospital
- Investigators
- People's Hospital Peking University, Study director, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03362216
- Sponsor's protocol ID
- PUPH20170999
- Status last verified
- Dec 2017
- First submitted
- 29 Nov 2017
- Last updated
- 8 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy and Safety of Compound Methyl Salicylate Liniment in the Treatment of Acute and Chronic Soft Tissue Pain：a Multicenter, Randomized, Positive Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03362216
- Acronym / sponsor ID
- PUPH20170999
- Conditions
- Soft Tissue Injuries
- Keywords
- soft tissue, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 7 Apr 2009 (actual)
- Primary completion
- 22 May 2009 (actual)
- Study completion
- 12 Jun 2009 (actual)
- First posted
- 5 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial program was established according to the ethical principles of the Helsinki declaration and the GCP guiding principle, and a randomized grouping method was used to evaluate the efficacy and safety of Compound Methyl Salicylate Liniment in the treatment of acute and chronic soft tissue pain with a positive control drug, named Diclofenac Sodium Liniment.
Detailed description
This study is a randomized, double-blind, parallel controlled multicenter clinical trial for evaluate the efficacy and safety of Compound Methyl Salicylate Liniment in the treatment of acute and chronic soft tissue pain with a positive control drug, named Diclofenac Sodium Liniment. A total of 216 participants with acute or chronic tissue pain participated in this clinical trial. The clinical trial cases were equally allocated to each research center, and each center had 30-35 cases. The proportion of patients with acute soft tissue pain and chronic soft tissue pain was 1:1, and the proportion of the experimental group and the control group was 1:1.The observation index include self pain scale record, tenderness scale and swelling, the evaluation period was 7 days.
The statistical analysis plan is prepared by the unit responsible for the statistics, and is prepared before the formal analysis of the data, and is discussed and identified at the blind audit meeting with the major researchers. Statistical analysis will use SAS8.2 statistical analysis software for data processing, and other statistical analysis plan to make detailed provisions. All the statistical tests were two-sided, and the value of P was less than or equal to 0.05, which would be considered statistically significant. Measurement data use case number, mean, standard deviation, minimum, maximum, median and four sub spacing description, counting data and grade data use case number, percentage description.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: Compound Methyl Salicylate LinimentTreated with Compound Methyl Salicylate Liniment group |
| Control group | Active comparator | Drug: Diclofenac Sodium LinimentTreated with Diclofenac Sodium Liniment group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with various causes of acute and chronic soft tissue
- Local symptoms and signs include pain, swelling, bruising, tenderness, joint dysfunction; X-ray showed no fracture, dislocation, bone tumors and bone metabolism and open injury.
Key exclusion criteria (11 listed)
- Patients who do not belong to the scope of drug use
- Muscle, tendon, ligament and other soft tissue have broken completely
- Accompanied by skin damage or fracture, joint dislocation, bone tumor and metabolic bone disease local tissue damage
- Use of other drugs or therapies for the treatment of acute and chronic soft tissue pain after trauma
- Difficult to evaluate the effectiveness and safety of new drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compound Methyl Salicylate LinimentCompound Methyl Salicylate Liniment, apply to the affected area, 3 times a day.Course of treatment: 7 days | Drug | experimental group |
| Diclofenac Sodium LinimentDiclofenac Sodium Liniment, apply to the affected area, 3 times a day. Course of treatment: 7 days | Drug | Control group |
Primary outcome
Main observation index
Time frame: 7 days
Self pain scale record (VAS). A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.Operationally a VAS is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end, the patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks, the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain.
1 secondary outcome
Secondary observation index
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
People's Hospital Peking University study director
Peking University
Questions about this trial
What is this clinical trial studying?
A study testing Compound Methyl Salicylate Liniment and Diclofenac Sodium Liniment in people with Soft Tissue Injuries, run by Peking University People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Main observation index (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2017.