Status:
COMPLETED
Evaluate the Analgesic Efficacy and Safety of VVZ-149 Injection for Postoperative Pain Following Total Hip Arthroplasty.
Lead Sponsor:
Vivozon, Inc.
Conditions:
Post-Operative Pain
Eligibility:
All Genders
25-65 years
Phase:
PHASE2
Brief Summary
The purpose of this phase 2 study is to evaluate the efficacy and safety of an analgesic drug candidate, VVZ-149 Injections. The study is designed as randomized, double-blind, parallel, and placebo-co...
Detailed Description
VVZ-149 is a dual antagonist of GlyT2 and 5HT2A. GlyT2 blockage increases inhibitory synaptic transmission by glycine in the spinal cord, resulting in a reduction of pain transmissions to the brain. 5...
Eligibility Criteria
Inclusion
- Patient between the ages of 25 and 65 years old
- Male patient, in the case of female patient, postmenopausal women, or women physically incapable of childbearing
- Subject who underwent surgery specially for the clinical study
- Ability to provide written informed consent prior to any study procedures.
- Ability to understand study procedures and communicate clearly with the investigator and staff.
- Subjects with body weight under 100kg and body mass index (BMI) level lower than 35 kg/m2, inclusive
- Single-side surgery patient
Exclusion
- \< Surgical Factors \>
- Emergency or unplanned surgery.
- Repeat operation
- \< Subject Characteristics \>
- Women with childbearing potential, Women who are pregnant or breastfeeding.
- 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.
- Unstable or acute medical condition (e.g., unstable angina, congestive heart failure, renal failure, hepatic failure, AIDS).
- Subjects who have long QPR (\>200msec) or prolonged QTc (\> 450msec in male, \>470msec in female) at Screening
- \< Drug, Alcohol, and Pharmacological Considerations \>
- History of alcohol, opiate or other drug abuse or dependence within 12 months prior to Screening .
- Ongoing or recent (within 6 hour prior to surgery) use of steroids, opioids, or antipsychotics.
- Alcohol consumption within 24 hours of surgery.
- Use of nonsteroidal anti-inflammatory drugs (NSAIDs) or acetaminophen within 6 hours of surgery.
- 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 \>
- Use of neuraxial or regional anesthesia related to the surgery.
- Use of ketamine, gabapentin, pregabalin, or lidocaine (\>1 mg/kg) intra or peri-operatively, or within 24 hours of surgery.
- Subject with known allergies to hydromorphone.
- Subjects who received another investigational drug within 30 days of scheduled surgery
Key Trial Info
Start Date :
December 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 19 2018
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03347266
Start Date
December 20 2017
End Date
July 19 2018
Last Update
March 13 2019
Active Locations (1)
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1
Yonsei University Health System, Severance Hospital
Seoul, South Korea