Clinical Efficacy and Safety of Compound Methyl Salicylate Liniment

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.

Study Overview

• Status: Completed
• Conditions: Soft Tissue Injuries
• Intervention / Treatment: Drug: Compound Methyl Salicylate Liniment; Drug: 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 Type: Interventional
• Enrollment (Actual): 216
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group; Treated with Compound Methyl Salicylate Liniment group	Drug: Compound Methyl Salicylate Liniment; Compound Methyl Salicylate Liniment, apply to the affected area, 3 times a day.Course of treatment: 7 days
Active Comparator: Control group; Treated with Diclofenac Sodium Liniment group	Drug: Diclofenac Sodium Liniment; Diclofenac Sodium Liniment, apply to the affected area, 3 times a day. Course of treatment: 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	7 days

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Investigators: Study Director: People's Hospital Peking University, Peking University

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2009
• Primary Completion (Actual): May 22, 2009
• Study Completion (Actual): June 12, 2009

Study Registration Dates

• First Submitted: November 29, 2017
• First Submitted That Met QC Criteria: November 29, 2017
• First Posted (Actual): December 5, 2017

Study Record Updates

• Last Update Posted (Actual): December 8, 2017
• Last Update Submitted That Met QC Criteria: December 6, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: soft tissue, pain
• Additional Relevant MeSH Terms: Wounds and Injuries; Soft Tissue Injuries; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Diclofenac; Salicylates; Methyl salicylate
• Other Study ID Numbers: PUPH20170999

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No