Study to Evaluate Analgesic Efficacy and Safety of Opiranserin Cream
- Conditions
- Diseases of the musculoskeletal system and connective tissue
- Registration Number
- KCT0007704
- Lead Sponsor
- Vivozon Healthcare
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 90
1. Men and women who are 19 to 70 years of age diagnosed with myofascial pain syndrome (including muscle tension, VDT, and turtle neck syndrome)
2. Female subjects who are not pregnant or breastfeeding.
3. Subjects who report the pain intensity 4 = on the NRS and moderate = on the VRS when pressing (without excessive stimulation of the trriger point) or moving the pain area
4. Subjects must have the ability to provide written informed consent.
5. Subjects who agree to collect the patient diary.
1. Women who are pregnant or breastfeeding.
2. Women with the possibility of pregnancy (premenopausal women except those who are in a medical condition that is not acquired or inherently impregnable) or are not planning to use medically acceptable contraceptives (e.g., oral contraceptives, intrauterine contraceptives, condoms, or diaphragms) during the study
3. Subject with muscle inflammation or muscle necrosis
4. Subjects with neurological that can cause pain or inflammatory conditions (such as sciatica, arthritis, neuromyopathy, fibromyalgia, sprain, etc.)
5. Subjects with surgical history at the pain site.
6. Subjects with a skin disease at the pain site.
7. Subjects with an unstable medical condition (e.g., unstable angina, congestive heart failure, renal failure, hepatic failure, or acquired immunodeficiency syndrome) or poorly controlled psychiatric conditions (e.g., post-traumatic stress disorder, anxiety, or depression).
8. History of alcohol, opiate, or other drug abuse or dependence within 12 months before the Screening Visit.
9. Subjects who use opioids or antipsychotics on screening visit and/or within 24 hours of treatment.
10. Subjects who use nonsteroidal anti-inflammatory drugs (NSAIDs), muscle relaxants, pain relief patches on the screening visit and/or within 24 hours of treatment.
11. Subjects with non-drug treatment (Physical therapy, laser therapy, acupuncture, moxibustion, massage, etc.) on screening visit and/or within 24 hours of treatment.
12. Subjects with alcohol consumption on screening visit and/or within 24 hours of treatment.
13. Subjects who received another investigational drug within 30 days prior to screening visit
14. Subjects who were determined to be unsuitable for this study by Investigator's judgment.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The time-weighted Sum of Pain intensity Difference (SPID) from baseline over 80min after the start of the Investigational Product (IP) application
- Secondary Outcome Measures
Name Time Method Pain Intensity Difference (PID) with NRS between visit 1 baseline and visit 2;PID with NRS between baseline and 80 min;Proportion of subjects with = 3 in pain intensity on visit 2;Pain intensity and pain relief index during self application period;Proportion of subjects who had used rescue medications and total number of rescue medication use during self application period;Global measurement of subject satisfaction