Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:03 PM
Ignite Modification Date:
2025-12-24 @ 4:03 PM
NCT ID:
NCT03347266
Eligibility Criteria:
Inclusion Criteria:
1. Patient between the ages of 25 and 65 years old
2. Male patient, in the case of female patient, postmenopausal women, or women physically incapable of childbearing
3. Subject who underwent surgery specially for the clinical study
4. Ability to provide written informed consent prior to any study procedures.
5. Ability to understand study procedures and communicate clearly with the investigator and staff.
6. Subjects with body weight under 100kg and body mass index (BMI) level lower than 35 kg/m2, inclusive
7. Single-side surgery patient
Exclusion Criteria:
\< Surgical Factors \>
1. Emergency or unplanned surgery.
2. Repeat operation
\< Subject Characteristics \>
3. Women with childbearing potential, Women who are pregnant or breastfeeding.
4. Unstable or poorly controlled psychiatric condition (e.g., untreated PTSD, anxiety, or depression). Subjects who take stable doses of antidepressants and anti-anxiety drugs may be included.
5. Unstable or acute medical condition (e.g., unstable angina, congestive heart failure, renal failure, hepatic failure, AIDS).
6. Subjects who have long QPR (\>200msec) or prolonged QTc (\> 450msec in male, \>470msec in female) at Screening
\< Drug, Alcohol, and Pharmacological Considerations \>
7. History of alcohol, opiate or other drug abuse or dependence within 12 months prior to Screening .
8. Ongoing or recent (within 6 hour prior to surgery) use of steroids, opioids, or antipsychotics.
9. Alcohol consumption within 24 hours of surgery.
10. Use of nonsteroidal anti-inflammatory drugs (NSAIDs) or acetaminophen within 6 hours of surgery.
11. Use of herbal agents or nutraceuticals (i.e., chaparral, comfrey, germander, jin bu huan, kava, pennyroyal, skullcap, St. John's wort, or valerian) within 7 days prior to surgery.
\< Anesthetic and Other Exclusion Considerations \>
12. Use of neuraxial or regional anesthesia related to the surgery.
13. Use of ketamine, gabapentin, pregabalin, or lidocaine (\>1 mg/kg) intra or peri-operatively, or within 24 hours of surgery.
14. Subject with known allergies to hydromorphone.
15. Subjects who received another investigational drug within 30 days of scheduled surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
65 Years
Study:
NCT03347266
Study Brief:
Protocol Section:
NCT03347266