AnalgesiaPhase 4NCT06458400
To Evaluate the Efficacy and Safety of Tegileridine and Oliceridine Injections in the Treatment of Postoperative Pain
A Phase 4 study testing Tegileridine, Oliceridine and Morphine in people with Analgesia, run by Yuwei Qiu at 1 site in China.
Trial summary
This was a single-center, randomized, open-label, controlled exploratory study conducted in Chinese patients. The study planned to enroll Chinese patients to evaluate the efficacy and safety of tegileridine and oliceridine injection in the treatment of postoperative pain. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Analgesia
- What is being tested?
- Tegileridine, Oliceridine and Morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- 3 Jul 2024to 6 Oct 2024
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Accept elective laparoscopic combined thoracic surgery under general anesthesia, surgery time ≥ 1 h;
- 18 years old ≤ age ≤70 years old, regardless of gender;
- 18 kg/m2≤BMI≤30 kg/m2;
- American Society of Anesthesiologists (ASA) grade ⅰ-ⅲ;
- Within 4 hours after the end of surgery, NRS≥4 in the resting state at any time;
- Before starting trial-related activities, participants should voluntarily sign the informed consent form, fully understand the purpose and significance of this trial, and voluntarily abide by the trial procedures.
Who cannot join
- Patients with a previous history of difficult airway (obstructive sleep apnea syndrome), severe respiratory depression such as oxygen saturation < 90%, or a history of acute or severe bronchial asthma;
- Patients with a history of severe cardiovascular and cerebrovascular diseases (such as myocardial infarction or unstable angina pectoris, or severe arrhythmia such as atrioventricular block of degree Ⅱ or above, or ischemic stroke in NYHA class Ⅱ or above);
- Known or suspected gastric bowel obstruction, including paralytic ileus patients;
- Patients with allergy to opioids or any component of the trial drug;
- Subjects with previous psychiatric disorders (such as schizophrenia, depression, etc.) and cognitive impairment;
- With late-stage malignant tumors or with extensive metastasis of malignant tumor patients;
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- Subjects with other somatic pain that may affect postoperative pain assessment;
- A history of drug, drug, and/or alcohol abuse within 1 year before randomization;
- Pregnant or lactating female subjects;
- Subjects with any other factor considered by the investigator to be ineligible for participation in the trial.
Trial locations and contacts
1 site in 1 country.
China1 site
241 Huaihai West Road, Xuhui District, Shanghai
Shanghai, Shanghai Municipality, 200000
About this study
This was a single-center, randomized, open-label, controlled exploratory study conducted in Chinese patients. The study planned to enroll Chinese patients to evaluate the efficacy and safety of tegileridine and oliceridine injection in the treatment of postoperative pain.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TegileridineDrug
single dose+PCA dose
OliceridineDrug
single dose+PCA dose
MorphineDrug
single dose+PCA dose
| Study group | Role | What they receive |
|---|---|---|
| tegileridine | Experimental | The loading iv dose: 0.75mg The PCIA dose：0.05mg Lockout time: 10min Receives: Drug: Tegileridine |
| oliceridine | Experimental | The loading iv dose: 1.5mg The PCIA dose：0.35mg Lockout time: 6min Receives: Drug: Oliceridine |
| morphine | Active comparator | The loading iv dose: 3mg The PCIA dose：1mg Lockout time: 6min Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-weighted sum of differences of resting pain score within 24 hours after starting a loading dose of test drug infusion
"resting pain score" is assessed by Numeric Rating Scale, range 0-10, 0=no pain and 10 = worst imaginable pain, from 0 to 0 means worse pain
Measured: during the first 24 hours after starting a loading dose of test drug infusion
Secondary outcomes (11)
Resting-state pain and exercise-state pain intensity
Resting-state pain and exercise-state pain intensity are assessed by Numeric Rating Scale, range 0-10, 0=no pain and 10 = worst imaginable pain, from 0 to 0 means worse pain
Measured: Pain scores are evaluated at 10 minutes、30 minutes、6 hours、12 hours、24 hours after the first loading dose
Time-weighted sum of differences of exercise-state pain score within 24 hours after starting a loading dose of test drug infusion
"exercise-state pain score" is assessed by Numeric Rating Scale, range 0-10, 0=no pain and
Measured: Pain scores are evaluated at 10 minutes、30 minutes、6 hours、12 hours、24 hours after the first loading dose
total pain relief (TOTPAR) scores
Time-weighted sum of resting and moving state pain relief scores
Measured: 10 minutes、30 minutes、6 hours、12 hours、24 hours after the first loading dose
the percentage of patients receiving rescue analgesia
the percentage of patients receiving rescue analgesia
Measured: from 0-24 hours after the first loading dose
length of bed stay
length out of bed
Measured: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 1 months.
Length of hospital stay
postoperative length of hospital stay
Measured: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 1 months.
incidence of Postoperative nausea and vomiting
incidence rate of PONV
Measured: the first 24 hours after surgery
incidence rate of respiratory depression
respiratory depression is defined as respiratory rate < 8 and/or SpO2<90%
Measured: the first 24 hours after surgery
analgesia satisfaction
satisfaction evaluation using 0-100 scale
Measured: the first 24 hours after surgery
pressing times of postoperative analgesic pump
Measured: the first 24 hours after surgery
total doses of postoperative analgesic pump
Measured: the first 24 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 posted13 Jun 2024
- Study start3 Jul 2024
- Primary completion30 Sep 2024
- Study completion6 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuwei Qiu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yuwei Qiu, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06458400
- Sponsor's protocol ID
- TGRD-ANAL-PILOT-001
- Status last verified
- Dec 2024
- First submitted
- 26 May 2024
- Last updated
- 1 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Share when necessary
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Efficacy and Safety of Tegileridine and Oliceridine Injections in the Treatment of Postoperative Pain
- ClinicalTrials.gov ID
- NCT06458400
- Acronym / sponsor ID
- TGRD-ANAL-PILOT-001
- Conditions
- Analgesia
- Keywords
- Analgesia, Biased μ-opioid receptor agonists
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Yuwei QiuUniversity, hospital or other
- Study start
- 3 Jul 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 6 Oct 2024 (actual)
- First posted
- 13 Jun 2024 (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 was a single-center, randomized, open-label, controlled exploratory study conducted in Chinese patients. The study planned to enroll Chinese patients to evaluate the efficacy and safety of tegileridine and oliceridine injection in the treatment of postoperative pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tegileridine | Experimental | Drug: TegileridineThe loading iv dose: 0.75mg The PCIA dose：0.05mg Lockout time: 10min |
| oliceridine | Experimental | Drug: OliceridineThe loading iv dose: 1.5mg The PCIA dose：0.35mg Lockout time: 6min |
| morphine | Active comparator | Drug: MorphineThe loading iv dose: 3mg The PCIA dose：1mg Lockout time: 6min |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Accept elective laparoscopic combined thoracic surgery under general anesthesia, surgery time ≥ 1 h;
- 18 years old ≤ age ≤70 years old, regardless of gender;
- 18 kg/m2≤BMI≤30 kg/m2;
- American Society of Anesthesiologists (ASA) grade ⅰ-ⅲ;
- Within 4 hours after the end of surgery, NRS≥4 in the resting state at any time;
Key exclusion criteria (10 listed)
- Patients with a previous history of difficult airway (obstructive sleep apnea syndrome), severe respiratory depression such as oxygen saturation < 90%, or a history of acute or severe bronchial asthma;
- Patients with a history of severe cardiovascular and cerebrovascular diseases (such as myocardial infarction or unstable angina pectoris, or severe arrhythmia such as atrioventricular block of degree Ⅱ or above, or ischemic stroke in NYHA class Ⅱ or above);
- Known or suspected gastric bowel obstruction, including paralytic ileus patients;
- Patients with allergy to opioids or any component of the trial drug;
- Subjects with previous psychiatric disorders (such as schizophrenia, depression, etc.) and cognitive impairment;
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 |
|---|---|---|
| Tegileridinesingle dose+PCA dose | Drug | tegileridine |
| Oliceridinesingle dose+PCA dose | Drug | oliceridine |
| Morphinesingle dose+PCA dose | Drug | morphine |
Primary outcome
Time-weighted sum of differences of resting pain score within 24 hours after starting a loading dose of test drug infusion
Time frame: during the first 24 hours after starting a loading dose of test drug infusion
"resting pain score" is assessed by Numeric Rating Scale, range 0-10, 0=no pain and 10 = worst imaginable pain, from 0 to 0 means worse pain
11 secondary outcomes
Resting-state pain and exercise-state pain intensity
Time frame: Pain scores are evaluated at 10 minutes、30 minutes、6 hours、12 hours、24 hours after the first loading dose
Time-weighted sum of differences of exercise-state pain score within 24 hours after starting a loading dose of test drug infusion
Time frame: Pain scores are evaluated at 10 minutes、30 minutes、6 hours、12 hours、24 hours after the first loading dose
total pain relief (TOTPAR) scores
Time frame: 10 minutes、30 minutes、6 hours、12 hours、24 hours after the first loading dose
the percentage of patients receiving rescue analgesia
Time frame: from 0-24 hours after the first loading dose
length of bed stay
Time frame: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 1 months.
Length of hospital stay
Time frame: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 1 months.
incidence of Postoperative nausea and vomiting
Time frame: the first 24 hours after surgery
incidence rate of respiratory depression
Time frame: the first 24 hours after surgery
analgesia satisfaction
Time frame: the first 24 hours after surgery
pressing times of postoperative analgesic pump
Time frame: the first 24 hours after surgery
total doses of postoperative analgesic pump
Time frame: the first 24 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 1 Jan 2025.
- Individual participant dataSharing planned: No. Share when necessary
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tegileridine, Oliceridine and Morphine in people with Analgesia, run by Yuwei Qiu at 1 site 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 6 inclusion and 10 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 1 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Time-weighted sum of differences of resting pain score within 24 hours after starting a loading dose of test drug infusion (time frame: during the first 24 hours after starting a loading dose of test drug infusion). 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 1 Jan 2025.