- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03347266
Evaluate the Analgesic Efficacy and Safety of VVZ-149 Injection for Postoperative Pain Following Total Hip Arthroplasty.
A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Analgesic Efficacy and Safety of VVZ-149 Injection for Post-operative Pain Following Total Hip Arthroplasty
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Seoul, Korea, Republic of
- Yonsei University Health system, Severance Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
< 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Placebo group will receive an water for injection the same volume and period of experimental group.
|
water for injection
Other Names:
|
Experimental: VVZ-149 injections
VVZ-149 injections will be mixed with saline, then intravenous infusion for 10hr.
The drug product will be administrated with a 1000mg for 10 hours.
|
•VVZ-149 injection
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Pain Intensity
Time Frame: prior to PCA, at 0,1, 2, 4, 6, 8, 10, 24 hours post-PCA
|
Change of Pain Intensity assessed using the Numerical Rating Scale (NRS, 0-10)
|
prior to PCA, at 0,1, 2, 4, 6, 8, 10, 24 hours post-PCA
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fentanyl Consumption
Time Frame: 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-16, 16-18, 18-20, 20-22, 22-24 hours post-PCA
|
the amount of fentanyl consumption over 24 hours
|
0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-16, 16-18, 18-20, 20-22, 22-24 hours post-PCA
|
the number of Fentanyl request
Time Frame: 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-16, 16-18, 18-20, 20-22, 22-24 hours post-PCA
|
the number of PCA request over 24 hours
|
0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-16, 16-18, 18-20, 20-22, 22-24 hours post-PCA
|
the amount of rescue dose
Time Frame: 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-16, 16-18, 18-20, 20-22, 22-24 hours post-dose
|
the amount of rescue dose over 24 hours
|
0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-16, 16-18, 18-20, 20-22, 22-24 hours post-dose
|
the number of requested rescue dose
Time Frame: 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-16, 16-18, 18-20, 20-22, 22-24 hours post-dose
|
the amount of requested rescue dose over 24 hours
|
0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-16, 16-18, 18-20, 20-22, 22-24 hours post-dose
|
Area under a curve (AUC) of Pain intensity and sum of AUC of pain intensity (SPI)
Time Frame: 0-1, 1-2, 2-4, 4-6, 6-8, 8-10, 10-24 hours post-PCA
|
the calculated AUC of Pain intensity and sum of AUC of pain intensity (SPI)
|
0-1, 1-2, 2-4, 4-6, 6-8, 8-10, 10-24 hours post-PCA
|
Global measurement of patient satisfaction assessed on the questionnaire (0-5 points scale)
Time Frame: 8, 24 hours post-PCA
|
the assessment of global satisfaction of patients using 0-5 points scale
|
8, 24 hours post-PCA
|
the correlation between Pharmacokinetic (PK) and Pharmacodynamic (PD)
Time Frame: 0, 2, 6 hours post-PCA
|
Correlation between total opioid consumption (fentanyl dose equivalents) and plasma exposure of study drug at 0, 2, 6 hours post-PCA
|
0, 2, 6 hours post-PCA
|
Number of Vomiting
Time Frame: 8, 24 hours post-PCA
|
the number of vomiting after PCA
|
8, 24 hours post-PCA
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PT-VVZ149-06
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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