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| Name | Class |
|---|---|
| Dong-A ST Co., Ltd. | INDUSTRY |
| Seoul National University Hospital | OTHER |
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**⑧-1. Visit 0: Pre-surgery Admission, Orthopedic Ward (Consent Acquisition and Screening)** According to the investigator's judgment, patients who are considered potential candidates will be encouraged to participate in the clinical trial. One day (±1 day) before surgery, the investigator or designated study staff will thoroughly explain the clinical trial process to the participant and their guardian (representative) based on the informed consent form and provide the form so that all participants and their guardians have sufficient time to read, discuss, and decide. Participants who agree to participate in the clinical trial will voluntarily sign the written consent form and receive a copy of the signed consent form before any study-related procedures are conducted. The clinical trial site will assign a screening number to patients who voluntarily provide consent and undergo screening. The screening number can be assigned in the order in which the participants sign the consent within the study site. After confirming eligibility based on inclusion/exclusion criteria, randomization will be performed to assign participants to either the treatment group or the control group (with a 1:1 ratio). If assigned to the treatment group, participants will receive 'Polmacoxib (preventive Acelex cap 2mg) once daily,' and NSAIDs-excluded non-opioid/opioid analgesics - PRN. If assigned to the control group, participants will receive NSAIDs-excluded non-opioid or opioid analgesics. Data will be collected by comparing the two groups in a double-arm setup. Pain scores, UCLA/ASES scores, and joint range of motion will be collected, and this data will be valid up to 3 months before the surgery.
**Visit 0 Investigations and Examinations:**
Obtain written consent
Assign screening number
Verify inclusion/exclusion criteria
Collect baseline information of the participant
Collect baseline disease information
Physical examination
Imaging data (MRI, X-ray, etc.)
UCLA/ASES scores (including pain scores)
Joint range of motion
Randomization
**Visit 1 Investigations and Examinations:**
Medication administration
**Visit 2 Investigations and Examinations:**
Pain scores
Physical examination
Check for adverse events
Cumulative number of NSAIDs-excluded non-opioid or opioid analgesic doses (post-surgery)
**Visit 3 Investigations and Examinations:**
Pain scores
Physical examination
Check for adverse events
Cumulative number of NSAIDs-excluded non-opioid or opioid analgesic doses (cumulative since surgery)
**Visit 4 Investigations and Examinations:**
Pain scores
Cumulative number of NSAIDs-excluded non-opioid or opioid analgesic doses (cumulative since surgery)
Physical examination
Check for adverse events
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental(Acelex cap 2mg) | Experimental | Experimental Arm (Polmacoxib (Acelex cap 2mg) + Non-NSAID Non-Opioid or Opioid Analgesics(ULTRACET ER SEMI TAB)) 1. Polmacoxib (preventive Acelex cap 2mg) administration, Method: One tablet orally once daily, regardless of meals. |
|
| Active Comparator(NSAIDs-excluded non-opioid or opioid analgesics) | Active Comparator | Control Group (Administration of Non-NSAID Non-Opioid or Opioid Analgesics(ULTRACET ER SEMI TAB)) 1. Non-NSAID Non-Opioid or Opioid Analgesics(ULTRACET ER SEMI TAB), Administration Method: PRN |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental(Acelex cap m2mg) | Drug | Experimental Arm (Polmacoxib (Acelex cap 2mg + NSAIDs-excluded non-opioid or opioid analgesics)) Polmacoxib (preventive Acelex cap 2mg) administered, dosage: 1 tablet orally once daily, regardless of meals. NSAIDs-excluded non-opioid or opioid analgesics, dosage: as needed (PRN). |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome Measure-Cumulative administration frequency of narcotic analgesics (e.g., Fentanyl injection), excluding NSAIDs | Postoperative pain in subjects is managed during the hospital stay by administering non-narcotic or narcotic analgesics, excluding NSAIDs (e.g., Fentanyl injection). Pain levels are assessed by collecting data on the frequency of administration. | At postoperative day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Outcome Measure-Cumulative number of doses of non-opioid analgesics excluding NSAIDs | - Cumulative number of doses of non-opioid analgesics excluding NSAIDs (e.g., Ultracet) | - 3 days post-surgery - 2 weeks post-surgery - 6 weeks post-surgery - 12 weeks post-surgery |
| Secondary Outcome Measure-Range of Motion (ROM) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| JAEMAN KWAK | Contact | +82 10-2300-6237 | jman.kwak@gmail.com | |
| SUIN JEONG | Contact | +82 10-7121-9335 | jeongsuin0622@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uijeongbu Eulji Medical Center, Eulji University | Recruiting | Uijeongbu-si | Gyeonggi-do | 11759 | South Korea |
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| Label | URL |
|---|---|
| Related Info | View source |
| Related Info | View source |
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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| ID | Term |
|---|---|
| D000701 | Analgesics, Opioid |
| ID | Term |
|---|---|
| D009294 | Narcotics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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Rotator cuff tear patients
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| Active Comparator(NSAIDs-excluded non-opioid or opioid analgesics) | Drug | NSAIDs-excluded non-opioid or opioid analgesics, dosage: as needed (PRN). |
|
Range of Motion (ROM) |
| 1 day before surgery, 12 weeks post-surgery |
| Secondary Outcome Measure-Rotator cuff re-tear status | Rotator cuff re-tear status | 12 weeks post-surgery |
| Secondary Outcome Measure |
The meaning of each number is as follows: 0: No pain 1-3: Mild pain 4-6: Moderate pain 7-9: Severe pain 10: Worst possible pain | - 1 day before surgery - 2 weeks post-surgery - 6 weeks post-surgery - 12 weeks post-surgery |
| Primary Outcome Measure-ASES score |
The ASES score consists of two key components: Pain Assessment: Patients rate their pain intensity on a numeric scale from 0 to 10, where 0 means no pain and 10 indicates severe pain. Functional Assessment: It includes 10 questions that evaluate daily shoulder and arm function. Each question is scored from 0 to 3, and this component plays a crucial role in assessing the patient's ability to perform daily activities. The final ASES score is calculated on a scale of 0 to 100, with higher scores indicating better shoulder function and less pain. This score helps healthcare professionals monitor shoulder conditions and evaluate treatment effectiveness. | 1 day before surgery, 12 weeks post-surgery |
| Secondary Outcome Measure-UCLA score |
The UCLA score is based on five components, totaling a maximum of 35 points: Pain (10 points): Evaluates the intensity of the patient's pain. Function (10 points): Assesses the patient's ability to use the shoulder in daily activities. Range of Motion (5 points): Measures the range of motion in the shoulder. Strength (5 points): Assesses the strength of the shoulder and arm. Patient Satisfaction (5 points): Evaluates how satisfied the patient is with their shoulder condition. Score Interpretation: 34-35 points: Excellent 28-33 points: Good 21-27 points: Fair 20 points or below: Poor The UCLA score provides a comprehensive assessment of shoulder pain and function, making it particularly useful for tracking recovery after procedures like arthroscopic shoul | 1 day before surgery, 12 weeks post-surgery |
| D020164 | Chemical Actions and Uses |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |