Post-operative PainPhase 2NCT06007066
HSK16149 for Perioperative Analgesia in Orthopedic Surgery
A Phase 2 study testing HSK16149 capsule in people with Post-operative Pain, run by Haisco Pharmaceutical Group Co., Ltd. at 21 sites in China.
Trial summary
This study will compare the effect and safety of HSK16149 with placebo on perioperative analgesia in orthopedic surgery, and explore the dosage of HSK16149 capsules for orthopedic analgesia during perioperative period. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Post-operative Pain
- What is being tested?
- HSK16149 capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 235 participants
- Where
- 21 sitesChina
- Study dates
- 8 Mar 2023to 5 Jul 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female between the ages of 18 and 75 years (included);
- Elective orthopedic surgery under general anesthesia, expected operation time ≤4 hours and postoperative morphine analgesia time ≥24 hours;
- 18kg/m^2≤BMI≤30 kg/m^2;
- American Society of Anesthesiologists (ASA) grade I and II;
Who cannot join
- Any of the following medical histories or conditions prior to screening:
- Long history of chronic pain;
- history of severe cardiovascular or respiratory disease;
- history of neurological or psychiatric disorders;
- history of acute poisoning with alcohol, hypnotics, analgesics or other drugs acting on the central nervous system;
- major surgery within 3 months;
Show all 18Show fewer
- patients with high bleeding risk;
- history of renal disease treated with dialysis within 28 days before surgery;
- have active infection within the past 2 weeks;
- Use of any of the following medications or treatments:
- opioid analgesics for more than 10 consecutive days within 3 months prior to screening;
- other analgesics before randomization if the last dose was taken less than 5 half-lives of the drug (according to the label);
- Abnormal laboratory tests during screening:
- Hypertension that is not adequately controlled by antihypertensive drugs (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg), or systolic blood pressure ≤90 mmHg during screening;
- A history of drug abuse, and/or alcohol abuse in the 3 months prior to screening;
- Participated in another clinical trial and received IMP within 30 days prior to screening;
- Pregnant or lactating women;
- Unwillingness to use reliable contraceptive methods from the time of screening until 28 days after the last dose of IMP;
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
China21 sites
Sino-Japanese Friendship Hospital
Beijing
Xiangya Third Hospital of Central South University
Changsha, Hunan
Chengdu Second People's Hospital
Chengdu, Sichuan
Chengdu Third People's Hospital
Chengdu, Sichuan
Sichuan Provincial People's Hospital
Chengdu, Sichuan
Dongguan People's Hospital
Dongguan, Guangdong
Foshan Fuxing Chancheng Hospital
Foshan, Guangdong
Guangyuan First People's Hospital
Guangyuan, Sichuan
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong
Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou
Beijing Jishuitan Hospital Guizhou Hospital
Guiyang, Guizhou
The First Affiliated Hospital of South China University
Hengyang, Hunan
The First People's Hospital of Yunnan Province
Kunming, Yunnan
Lianyungang First People's Hospital
Lianyungang, Jiangsu
Mianyang Central Hospital
Mianyang, Sichuan
Nanjing First Hospital
Nanjing, Jiangsu
People's Hospital of Wuhan University
Wuhan, Hubei
Wuhan Central Hospital
Wuhan, Hubei
Yibin Second People's Hospital
Yibin, Sichuan
Henan Provincial People's Hospital
Zhengzhou, Henan
Zunyi University Affiliated Hospital
Zunyi, Guizhou
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-controlled Phase II Study of The Efficacy And Safety of HSK16149 In The Treatment of Patients With Orthopedic Perioperative Analgesia
This study will compare the effect and safety of HSK16149 with placebo on perioperative analgesia in orthopedic surgery, and explore the dosage of HSK16149 capsules for orthopedic analgesia during perioperative period.
Read the detailed description
This study included patients who have orthopedic surgery under general anesthetic, with expected operation time ≤4h.
Subjects were given 40mg or 60mg of HSK16149 or placebo orally the night before surgery, 2h before surgery, 4h and 16h after surgery, for a total of 4 times during the whole treatment period.
Subjects will receive intravenous patient-controlled analgesia (PCA) morphine for pain in the immediate postoperative period. If PCA is insufficient, rescue analgesia of morphine may be given I.V. as determined by the investigator.
After the treatment period, the subjects will be followed up.
- Conditions
- Post-operative Pain
- Being tested
- HSK16149 capsule, Placebo
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK16149 capsuleDrug
Also called HSK16149
Subjects will be given 40mg or 60mg of HSK16149 orally.
PlaceboDrug
Also called HSK16149 placebo
Subjects will be given HSK16149 placebo orally.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative administration of HSK16149 40mg | Experimental | HSK16149 40mg will be administered the night before and 2h before surgery Receives: Drug: HSK16149 capsule |
| Preoperative administration of HSK16149 60mg | Experimental | HSK16149 60mg will be administered the night before and 2h before surgery Receives: Drug: HSK16149 capsule |
| Preoperative and postoperative administration of HSK16149 40mg | Experimental | HSK16149 40mg will be administered orally the night before surgery, 2h before surgery, 4h and 16h after surgery Receives: Drug: HSK16149 capsule |
| Preoperative and postoperative administration of HSK16149 60mg | Experimental | HSK16149 60mg will be administered orally the night before surgery, 2h before surgery, 4h and 16h after surgery Receives: Drug: HSK16149 capsule |
| placebo | Placebo comparator | The placebo will be administered orally the night before surgery, 2h before surgery, 4h and 16h after surgery Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine Consumption
IV Patient Controlled Analgesia (PCA) morphine for pain management in the immediate postoperative period for an average of 24 hours after surgery. If PCA is insufficient, rescue analgesia of morphine may be given I.V. as determined by the investigator.
Total morphine consumption = PCA morphine consumption + rescue analgesia morphine consumption.
Measured: Participants received PCA pump, an average of 24 hours after surgery
Secondary outcomes (9)
NRS at rest and during exercise
NRS:0 (no pain) to 10 (worst possible pain)
Measured: 1, 2, 6, 12, 18, and 24 hours after surgery
Time of first rescue analgesia with morphine after surgery
Measured: Within 24 hours after surgery
Incidence of adverse reactions associated with morphine
Measured: Within 24 hours after surgery
The frequency of rescue analgesia with morphine
Measured: Within 24 hours after surgery
The total number of PCA presses and the number of effective PCA presses
Measured: Within 24 hours after surgery
Daily Sleep Interference Scale (DSIS)
Subjects review their sleep status during the past 12 hours at 8:00 a.m. on the day of surgery.
DSIS: 0 (not affecting sleep) to 10 (unable to sleep)
Measured: Within 24 hours after surgery
Subjects analgesic satisfaction score
Analgesic satisfaction score: 0 (not satisfied) to 10 (very satisfied)
Measured: Within 24 hours after surgery
Investigators analgesic satisfaction score
Analgesic satisfaction score: 0 (not satisfied) to 10 (very satisfied)
Measured: Within 24 hours after surgery
Number of participants with treatment-related adverse events(TEAE) as assessed by CTCAE v5.0.
Number and severity of AEs, clinical laboratory abnormalities, physical examinations, 12-lead electrocardiograms (ECGs)(including QT Interval,QTc Interval and PR Interval), and vital signs.
Measured: From enrollment to 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start8 Mar 2023
- Primary completion12 Jun 2023
- Study completion5 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative PainStudies of the same condition, open and under way.
- More trials run by Haisco Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06007066
- Sponsor's protocol ID
- HSK16149-204
- Status last verified
- Aug 2023
- First submitted
- 5 Mar 2023
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-controlled Phase II Study of The Efficacy And Safety of HSK16149 In The Treatment of Patients With Orthopedic Perioperative Analgesia
- ClinicalTrials.gov ID
- NCT06007066
- Acronym / sponsor ID
- HSK16149-204
- Conditions
- Post-operative Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Mar 2023 (actual)
- Primary completion
- 12 Jun 2023 (actual)
- Study completion
- 5 Jul 2023 (actual)
- First posted
- 23 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the effect and safety of HSK16149 with placebo on perioperative analgesia in orthopedic surgery, and explore the dosage of HSK16149 capsules for orthopedic analgesia during perioperative period.
Detailed description
This study included patients who have orthopedic surgery under general anesthetic, with expected operation time ≤4h.
Subjects were given 40mg or 60mg of HSK16149 or placebo orally the night before surgery, 2h before surgery, 4h and 16h after surgery, for a total of 4 times during the whole treatment period.
Subjects will receive intravenous patient-controlled analgesia (PCA) morphine for pain in the immediate postoperative period. If PCA is insufficient, rescue analgesia of morphine may be given I.V. as determined by the investigator.
After the treatment period, the subjects will be followed up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Preoperative administration of HSK16149 40mg | Experimental | Drug: HSK16149 capsuleHSK16149 40mg will be administered the night before and 2h before surgery |
| Preoperative administration of HSK16149 60mg | Experimental | Drug: HSK16149 capsuleHSK16149 60mg will be administered the night before and 2h before surgery |
| Preoperative and postoperative administration of HSK16149 40mg | Experimental | Drug: HSK16149 capsuleHSK16149 40mg will be administered orally the night before surgery, 2h before surgery, 4h and 16h after surgery |
| Preoperative and postoperative administration of HSK16149 60mg | Experimental | Drug: HSK16149 capsuleHSK16149 60mg will be administered orally the night before surgery, 2h before surgery, 4h and 16h after surgery |
| placebo | Placebo comparator | Drug: PlaceboThe placebo will be administered orally the night before surgery, 2h before surgery, 4h and 16h after surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female between the ages of 18 and 75 years (included);
- Elective orthopedic surgery under general anesthesia, expected operation time ≤4 hours and postoperative morphine analgesia time ≥24 hours;
- 18kg/m^2≤BMI≤30 kg/m^2;
- American Society of Anesthesiologists (ASA) grade I and II;
Key exclusion criteria (18 listed)
- Any of the following medical histories or conditions prior to screening:
- Use of any of the following medications or treatments:
- Abnormal laboratory tests during screening:
- Hypertension that is not adequately controlled by antihypertensive drugs (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg), or systolic blood pressure ≤90 mmHg during screening;
- A history of drug abuse, and/or alcohol abuse in the 3 months prior to screening;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HSK16149 capsuleAlso: HSK16149Subjects will be given 40mg or 60mg of HSK16149 orally. | Drug | Preoperative administration of HSK16149 40mg, Preoperative administration of HSK16149 60mg, Preoperative and postoperative administration of HSK16149 40mg, Preoperative and postoperative administration of HSK16149 60mg |
| PlaceboAlso: HSK16149 placeboSubjects will be given HSK16149 placebo orally. | Drug | placebo |
Primary outcome
Morphine Consumption
Time frame: Participants received PCA pump, an average of 24 hours after surgery
IV Patient Controlled Analgesia (PCA) morphine for pain management in the immediate postoperative period for an average of 24 hours after surgery. If PCA is insufficient, rescue analgesia of morphine may be given I.V. as determined by the investigator. Total morphine consumption = PCA morphine consumption + rescue analgesia morphine consumption.
9 secondary outcomes
NRS at rest and during exercise
Time frame: 1, 2, 6, 12, 18, and 24 hours after surgery
Time of first rescue analgesia with morphine after surgery
Time frame: Within 24 hours after surgery
Incidence of adverse reactions associated with morphine
Time frame: Within 24 hours after surgery
The frequency of rescue analgesia with morphine
Time frame: Within 24 hours after surgery
The total number of PCA presses and the number of effective PCA presses
Time frame: Within 24 hours after surgery
Daily Sleep Interference Scale (DSIS)
Time frame: Within 24 hours after surgery
Subjects analgesic satisfaction score
Time frame: Within 24 hours after surgery
Investigators analgesic satisfaction score
Time frame: Within 24 hours after surgery
Number of participants with treatment-related adverse events(TEAE) as assessed by CTCAE v5.0.
Time frame: From enrollment to 72 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Post-operative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HSK16149 capsule in people with Post-operative Pain, run by Haisco Pharmaceutical Group Co., Ltd. at 21 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine Consumption (time frame: Participants received PCA pump, an average of 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2023.