Clinical trial NCT03362216: Clinical Efficacy and Safety of Compound Methyl Salicylate Liniment
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Soft Tissue Injuries
Keywords: soft tissue, pain
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2017-12-05
Enrollment: 216
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Main observation index
timeFrame: 7 days
Secondary outcomes:
measure: Secondary observation index
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
affiliation: Peking University
name: People's Hospital Peking University
role: STUDY_DIRECTOR
References: