Respiratory InsufficiencyPhase 2/3NCT06785571
The Evaluation of the Effectiveness and Safety of Nalbuphine Hydrochloride Injection for Analgesia in ICU Patients: A Multicenter, Randomized, Single-blinded, Parallel, Two-step Trial
A Phase 2/3 study testing Nalbuphine hydrochloride injection and Hydromorphone hydrochloride injection in people with Respiratory Insufficiency, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
The analgesic effect of nalbuphine hydrochloride injection will be evaluated in a multicenter, randomized, single-blind, parallel, positive-controlled approach in two steps: step 1, to explore the optimal dosage of nalbuphine hydrochloride injection with 2 experimental arms and 1 positive control and step 2, to… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Respiratory Insufficiency
- What is being tested?
- Nalbuphine hydrochloride injection and Hydromorphone hydrochloride injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2023to 31 Oct 2025
- Phase
- Phase 2/3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ICU patients who are intubated are expected to require mechanical ventilation for more than 6h
- patients or their guardians have a full understanding of the purpose and significance of this trial, and voluntarily participate in this clinical trial and sign an informed consent form
Who cannot join
- Allergy or unsuitability to any composition of study drugs or propofol
- Living expectancy of less than 48 hours
- Neurological disorder and any other condition interfering with sedation assessment
- Gastrointestinal obstruction
- Asthmatic
- Abdominal compartment syndrome
Show all 15Show fewer
- Serious hepatic dysfunction (CTP 10-15)
- Acute kidney injury (KDIGO stage 2 or 3) or Chronic kidney disease with glomerular filtration rate (GFR) < 29 ml/min/1.73m2
- Circulatory instability (the need for a continuous infusion of norepinephrine at ≥0.5 ug/kg/min to maintain proper blood pressure)
- Need deep sedation or paralytics
- Anticipation to receive operations (including tracheotomy)
- Abuse of controlled substances or alcohol
- Pregnancy, lactation, or an intention of gestation in 6 months
- Inclusion in another interventional trial in the past 30 days
- Other conditions deemed unsuitable to be included
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wuhan Union Hospital
Wuhan, Hubei, 430022
You Shang, 15972127819, you_shanghust@163.com
About this study
The analgesic effect of nalbuphine hydrochloride injection will be evaluated in a multicenter, randomized, single-blind, parallel, positive-controlled approach in two steps: step 1, to explore the optimal dosage of nalbuphine hydrochloride injection with 2 experimental arms and 1 positive control and step 2, to evaluate the effectiveness and safety of nalbuphine hydrochloride injection in mechanically ventilated ICU patients at a dosage determined in step 1 with the same positive control.
- Conditions
- Respiratory Insufficiency
- Being tested
- Nalbuphine hydrochloride injection, Hydromorphone hydrochloride injection
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nalbuphine hydrochloride injectionDrug
a loading dose of Nalbuphine hydrochloride injection administered in 30 ±10 seconds, followed by a maintenance dose of 2.0mg/h (a recommended maintenance dose range of 1.0~5.0mg/h)
Hydromorphone hydrochloride injectionDrug
A maintenance dose of 0.5mg/h (a recommended maintenance dose range of 0.5~3.0mg/h)
| Study group | Role | What they receive |
|---|---|---|
| lower loading dose of Nalbuphine hydrochloride for step 1 | Experimental | Nalbuphine hydrochloride injection, a loading dose of 4 mg administered in 30 ±10 seconds, followed by a maintenance dose of 2.0mg/h (a recommended maintenance dose range of 1.0~5.0mg/h) Receives: Drug: Nalbuphine hydrochloride injection |
| higher loading dose of Nalbuphine hydrochloride for step 1 | Experimental | Nalbuphine hydrochloride injection, a loading dose of 6 mg administered in 30 ±10 seconds, followed by a maintenance dose of 2.0mg/h (a recommended maintenance dose range of 1.0~5.0mg/h) Receives: Drug: Nalbuphine hydrochloride injection |
| Hydromorphone hydrochloride injection for step 1 | Active comparator | Hydromorphone hydrochloride injection: a maintenance dose of 0.5mg/h (a recommended maintenance dose range of 0.5~3.0mg/h) Receives: Drug: Hydromorphone hydrochloride injection |
| The optimal loading of Nalbuphine hydrochloride injection for step 2 | Experimental | Nalbuphine hydrochloride injection: a loading dose determined after step 1 administered in 30 ±10 seconds, followed by a maintenance dose of 2.0mg/h (a recommended maintenance dose range of 1.0~5.0mg/h) Receives: Drug: Nalbuphine hydrochloride injection |
| Hydromorphone hydrochloride injection for step 2 | Active comparator | Hydromorphone hydrochloride injection: a maintenance dose of 0.5mg/h (a recommended maintenance dose range of 0.5~3.0mg/h) Receives: Drug: Hydromorphone hydrochloride injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The analgesic success rate
The analgesic success is determined as 1) no use of rescue analgesic medication and 2) at least 70% of the time with CPOT ≤ 2 points
Measured: Within 24 hours while receiving the study drug
Secondary outcomes (3)
The percentage of time with light sedation duration
Light sedation duration is defined as subjects with CPOT ≤ 2 points and -2 points ≤ RASS ≤ 1
Measured: Within 24 hours while receiving the study drug
The amout of propfol used
The amout of propfol used
Measured: Within 24 hours while receiving the study drug
Successful extubation
Successful extubated without reintubation
Measured: Within 24 hours while receiving the study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2025
- Study start30 Aug 2023
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Yichang Humanwell Pharmaceutical Co., Ltd., China
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06785571
- Sponsor's protocol ID
- 2023-0407
- Status last verified
- Oct 2024
- First submitted
- 9 Jan 2025
- Last updated
- 21 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang Y, Yuan Y, Ren L, Jiang W, Sun S, Wang R, Li Z, Peng Q, Gong R, Yang X, Shang Y. Protocol for a multicenter, randomized, single-blind, non-inferiority trial comparing nalbuphine hydrochloride versus hydromorphone hydrochloride for analgesia in mechanically ventilated ICU patients. Front Pharmacol. 2026 Apr 28;17:1795531. doi: 10.3389/fphar.2026.1795531. eCollection 2026.
PubMed 42131816
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of the Effectiveness and Safety of Nalbuphine Hydrochloride Injection for Analgesia in ICU Patients: A Multicenter, Randomized, Single-blinded, Parallel, Two-step Trial
- ClinicalTrials.gov ID
- NCT06785571
- Acronym / sponsor ID
- 2023-0407
- Conditions
- Respiratory Insufficiency
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Yichang Humanwell Pharmaceutical Co., Ltd., China
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 21 Jan 2025 (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.
The analgesic effect of nalbuphine hydrochloride injection will be evaluated in a multicenter, randomized, single-blind, parallel, positive-controlled approach in two steps: step 1, to explore the optimal dosage of nalbuphine hydrochloride injection with 2 experimental arms and 1 positive control and step 2, to evaluate the effectiveness and safety of nalbuphine hydrochloride injection in mechanically ventilated ICU patients at a dosage determined in step 1 with the same positive control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| lower loading dose of Nalbuphine hydrochloride for step 1 | Experimental | Drug: Nalbuphine hydrochloride injectionNalbuphine hydrochloride injection, a loading dose of 4 mg administered in 30 ±10 seconds, followed by a maintenance dose of 2.0mg/h (a recommended maintenance dose range of 1.0~5.0mg/h) |
| higher loading dose of Nalbuphine hydrochloride for step 1 | Experimental | Drug: Nalbuphine hydrochloride injectionNalbuphine hydrochloride injection, a loading dose of 6 mg administered in 30 ±10 seconds, followed by a maintenance dose of 2.0mg/h (a recommended maintenance dose range of 1.0~5.0mg/h) |
| Hydromorphone hydrochloride injection for step 1 | Active comparator | Drug: Hydromorphone hydrochloride injectionHydromorphone hydrochloride injection: a maintenance dose of 0.5mg/h (a recommended maintenance dose range of 0.5~3.0mg/h) |
| The optimal loading of Nalbuphine hydrochloride injection for step 2 | Experimental | Drug: Nalbuphine hydrochloride injectionNalbuphine hydrochloride injection: a loading dose determined after step 1 administered in 30 ±10 seconds, followed by a maintenance dose of 2.0mg/h (a recommended maintenance dose range of 1.0~5.0mg/h) |
| Hydromorphone hydrochloride injection for step 2 | Active comparator | Drug: Hydromorphone hydrochloride injectionHydromorphone hydrochloride injection: a maintenance dose of 0.5mg/h (a recommended maintenance dose range of 0.5~3.0mg/h) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ICU patients who are intubated are expected to require mechanical ventilation for more than 6h
- patients or their guardians have a full understanding of the purpose and significance of this trial, and voluntarily participate in this clinical trial and sign an informed consent form
Key exclusion criteria (15 listed)
- Allergy or unsuitability to any composition of study drugs or propofol
- Living expectancy of less than 48 hours
- Neurological disorder and any other condition interfering with sedation assessment
- Gastrointestinal obstruction
- Asthmatic
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 |
|---|---|---|
| Nalbuphine hydrochloride injectiona loading dose of Nalbuphine hydrochloride injection administered in 30 ±10 seconds, followed by a maintenance dose of 2.0mg/h (a recommended maintenance dose range of 1.0~5.0mg/h) | Drug | The optimal loading of Nalbuphine hydrochloride injection for step 2, higher loading dose of Nalbuphine hydrochloride for step 1, lower loading dose of Nalbuphine hydrochloride for step 1 |
| Hydromorphone hydrochloride injectionA maintenance dose of 0.5mg/h (a recommended maintenance dose range of 0.5~3.0mg/h) | Drug | Hydromorphone hydrochloride injection for step 1, Hydromorphone hydrochloride injection for step 2 |
Primary outcome
The analgesic success rate
Time frame: Within 24 hours while receiving the study drug
The analgesic success is determined as 1) no use of rescue analgesic medication and 2) at least 70% of the time with CPOT ≤ 2 points
3 secondary outcomes
The percentage of time with light sedation duration
Time frame: Within 24 hours while receiving the study drug
The amout of propfol used
Time frame: Within 24 hours while receiving the study drug
Successful extubation
Time frame: Within 24 hours while receiving the study drug
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2025.
- Derived from this study: PubMed 42131816Zhang Y, Yuan Y, Ren L, Jiang W, Sun S, Wang R, Li Z, Peng Q, Gong R, Yang X, Shang Y. Protocol for a multicenter, randomized, single-blind, non-inferiority trial comparing nalbuphine hydrochloride versus hydromorphone hydrochloride for analgesia in mechanically ventilated ICU patients. Front Pharmacol. 2026 Apr 28;17:1795531. doi: 10.3389/fphar.2026.1795531. eCollection 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Nalbuphine hydrochloride injection and Hydromorphone hydrochloride injection in people with Respiratory Insufficiency, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 2 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 21 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact you shang (02785351606, you_shanghust@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The analgesic success rate (time frame: Within 24 hours while receiving the study drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06785571, which also lists 1 linked publication.
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 21 Jan 2025.