Status Approved
First Submitted Date
2017/11/24
Registered Date
2018/01/09
Last Updated Date
2021/10/05
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0002653 |
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Unique Protocol ID | PT-VVZ149-06 |
Public/Brief Title | 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 |
Scientific Title | 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 |
Acronym | |
MFDS Regulated Study | Yes |
IND/IDE Protocol | Yes |
Registered at Other Registry | Yes |
Name of Registry / Registration Number | ClinicalTrials.gov-NCT03347266 |
Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | 4-2017-0775 |
Approval Date | 2017-09-29 |
Institutional Review Board Name | Yonsei University Health System, Severance Hospital, Institutional Review Board |
Institutional Review Board Address | 50-1, Yonsei-ro, Seodaemun-gu, Seoul, Republic of Korea |
Institutional Review Board Telephone | 02-2227-7889 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Sun Joon Bai |
Title | MD, PhD |
Telephone | +82-2-2227-3834 |
Affiliation | Yonsei University Health System, Severance Hospital |
Address | 50-1 Yonse-ro, Seodaemun-gu, Seoul, 03722, Korea |
Contact Person for Public Queries | |
Name | Na Young Kim |
Title | MD, PhD |
Telephone | +82-2-2227-3549 |
Affiliation | Yonsei University Health System, Severance Hospital |
Address | 50-1 Yonse-ro, Seodaemun-gu, Seoul, 03722, Korea |
Contact Person for Updating Information | |
Name | Jina Kim |
Title | MS |
Telephone | +82-2-916-1004 |
Affiliation | Vivozon |
Address | 357, Guseong-ro, Giheung-gu, Yongin-si, Gyeonggi-do, Republic of Korea |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Terminated | |
Date of First Enrollment | 2017-12-20 Actual | |
Target Number of Participant | 20 | |
Primary Completion Date | 2018-07-19 , Actual | |
Study Completion Date | 2018-07-19 , Actual | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Yonsei University Health System, Severance Hospital | |
Recruitment Status | Terminated Terminated Reason : 모집중단 | |
Date of First Enrollment | 2017-12-20 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Vivozon |
Organization Type | Pharmaceutical Company |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Vivozon |
Organization Type | Pharmaceutical Company |
7. Study Summary
Lay Summary | 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. 5HT2A blockage decreases descending serotonergic facilitatory modulation on pain transmission by the brain and reduces nociceptor activation in peripheral nerves, which are primary sources of pain in post-surgical pain. VVZ-149 has been shown to have comparable efficacy to morphine in well-controlled (blind, complete randomization with a positive control) animal studies using rat models of post-operative pain and formalin-induced pain. The Pharmacokinetics/Pharmacodynamics study in animals indicates that therapeutic plasma concentration in human subjects will be 600-1,900 ng/ml. A clinical Phase 1 study performed in healthy subjects has shown no clinically significant adverse events up to a plasma concentration level of 3,261 ng/ml other than brief symptoms of mild nausea or dizziness, and mild somnolence when the plasma exposure level is more than 2,000 ng/ml. Phase 2 was designed as a randomized, double-blind, parallel-group, placebo-controlled trial to evaluate the efficacy and safety of the analgesic drug VVZ-149 injection. The interim analysis of phase 2 study showed that the protocol is appropriate to evaluate the efficacy. The new phase 2 study tries to determine the direction of the clinical trial by verifying that the pain resulting from the hip bone muscle is beneficial to the bone muscle. The drug is administered when they arrive in the operating room. <A Primary objective> Assessment of the efficacy of VVZ-149 for postoperative pain (1,000 mg IV infusion for 10 hrs) <A Secondary objective> Pharmacokinetics/Pharmacodynamics correlation evaluation Safety evaluation of VVZ-149 |
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8. Study Design
Study Type | Interventional Study |
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Study Purpose | Treatment |
Phase | Phase2 |
Intervention Model | Parallel |
Blinding/Masking | Double |
Blinded Subject | Subject, Investigator, Caregiver |
Allocation | RCT |
Intervention Type | Drug |
Intervention Description | 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 Placebo Placebo group will receive an water for injection the same volume and period of experimental group. |
Number of Arms | 2 |
Arm 1 |
Arm Label VVZ-149 Injections |
Target Number of Participant 10 |
|
Arm Type Experimental |
|
Arm Description 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, In addition, administer remedies to patients according to the needs of the patient for adequate pain control, or inject them with a plasma injection (PCA, Fentanyl IV bolus, 6 minutes). |
|
Arm 2 |
Arm Label Placebo |
Target Number of Participant 10 |
|
Arm Type Placebo comparator |
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Arm Description Placebo group will receive an water for injection the same volume and period of experimental group In addition, administer remedies to patients according to the needs of the patient for adequate pain control, or inject them with a plasma injection (PCA, Fentanyl IV bolus, 6 minutes).. |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (M00-M99)Diseases of the musculoskeletal system and connective tissue (M16.9)Coxarthrosis, unspecified Arthroplasty, Replacement, Hip Pain, Postoperative |
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Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 25Year~65Year |
|
Description 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 |
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 Post traumatic stress disorder, 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 Q wave, R wave and S wave (>200msec) or prolonged Corrected QT Interval (> 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 | No |
10. Outcome Measure(s)
Type of Primary Outcome | Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | Pain Intensity (Numerical Rating Scale, 0-10, NRS at rest) |
|
Timepoint | after onset of PCA, 0, 1, 2, 4, 6, 8, 10, 24 hours |
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Secondary Outcome(s) 1 | ||
Outcome | Amount of Fentanyl consumption after administration of investigational drug |
|
Timepoint | 0-24 hours, 2 hours interval |
|
Secondary Outcome(s) 2 | ||
Outcome | Amount of relief medication consumed of investigational drug number of requests |
|
Timepoint | 0-24 hours, 2 hours interval |
|
Secondary Outcome(s) 3 | ||
Outcome | Total Amount of Fentanyl consumption and rescue dose |
|
Timepoint | 0-24 hours, 2 hours interval |
|
Secondary Outcome(s) 4 | ||
Outcome | Pain Intensity Difference and Sum Pain Intensity Difference |
|
Timepoint | after onset of PCA, 0-1, 1-2, 2-4, 4-6, 6-8, 8-10, 10-24 hours |
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Secondary Outcome(s) 5 | ||
Outcome | global measurement of patient satisfaction |
|
Timepoint | 8, 24 hours after onset of PCA |
|
Secondary Outcome(s) 6 | ||
Outcome | Pharmacokinetics/Pharmacodynamics correlation |
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Timepoint | 0, 4 ,6 hours after onset of PCA |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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