Acute Chest PainPhase 1/2NCT06949059
Intravenous Hydromorphone for the Treatment of Acute Pain
A Phase 1/2 study testing Hydromorphone in people with Acute Chest Pain, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
To observe the efficacy and safety of hydromorphone in the treatment of acute chest pain, and to explore the potential advantages of hydromorphone for analgesia in patients with acute chest pain, so as to provide more theoretical basis for individualized analgesia and rapid recovery in patients with acute chest pain. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Acute Chest Pain
- What is being tested?
- Hydromorphone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 31 Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-64 years old;
- Gender is not limited;
- Patients with acute chest pain, with the time from pain onset to visit the doctor ≤ 24 days;
- Severe pain that requires the use of opioids to control as determined by emergency physicians;
- Obtain informed consent from the patient or family members.
Who cannot join
- Known allergy to hydromorphone or morphine;
- Systolic blood pressure <100 mmHg, oxygen saturation <95%, pulse less than 60 beats/min;
- Use of acetaminophen or nonsteroidal anti-inflammatory drugs in the past 8 hours;
- Chronic pain, defined as pain lasting for more than 12 weeks;
- Delirium, alcohol withdrawal symptoms or other drug intoxication;
- Pregnant or lactating women;
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- Patients with mental or neurological diseases, cognitive and consciousness disorders and inability to express correctly;
- Participating in any other research at the same time;
- Factors that increase the risk of participating in the study (life-threatening chest pain patients who require rapid diagnosis or treatment intervention, such as resuscitation status, excluding chest pain caused by myocardial infarction), who are judged by the researchers to be unsuitable for inclusion in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008
Hao Sun, MD, PhD, 13584017821 ext. 86, haosun_6@163.com
About this study
Official title: Intravenous Acetaminophen Versus Intravenous Hydromorphone for the Treatment of Acute Pain: A Single-Center, Prospective, Single-Arm Study
To observe the efficacy and safety of hydromorphone in the treatment of acute chest pain, and to explore the potential advantages of hydromorphone for analgesia in patients with acute chest pain, so as to provide more theoretical basis for individualized analgesia and rapid recovery in patients with acute chest pain.
- Conditions
- Acute Chest Pain
- Being tested
- Hydromorphone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydromorphoneDrug
Hydromorphone 1mg was given intravenously and conventional treatment was performed at the same time.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Hydromorphone 1mg was given intravenously and conventional treatment was performed at the same time. Receives: Drug: Hydromorphone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Relief at 30 Minutes After Administration
The difference between the NRS pain score before medication and the NRS pain score at 30 minutes after administration (i.e., NRS_before-NRS_at_30min). A larger value indicates a better analgesic effect.
Measured: 30 minutes post-medication
Secondary outcomes (8)
NRS Pain Scores Over 60 Minutes
NRS pain scores will be measured at baseline (before administration) and at 5, 15, 30, 45, and 60 minutes post-administration. If additional analgesics or rescue medication are given, the NRS is re-measured 5 minutes afterward.
Measured: 0, 5, 15, 30, 45, and 60 minutes after administration (plus 5 minutes after any additional dose)
Analgesia Success Rate
The proportion of patients who do not require any additional analgesics within 60 minutes after the initial administration.
Measured: Up to 60 minutes post-administration
Adverse Events Within 60 Minutes
Incidence of adverse events (e.g., hypoventilation, bradycardia, nausea, vomiting, itching, or requirement of naloxone) within 60 minutes after administration.
Measured: 60 minutes post-administration
Total Dose of Rescue Medication
The cumulative dose of any rescue medication administered within 60 minutes after the initial analgesic administration.
Measured: 60 minutes post-administration
Blood Drug Concentration
Measurement of drug concentrations from blood samples collected at baseline, 2, 6, 12, and 24 hours after administration, to assess pharmacokinetics.
Measured: Baseline; 2, 6, 12, and 24 hours post-administration
Oxygen Saturation
Measurement of oxygen saturation recorded at baseline, 15, 30, 45, and 60 minutes post-administration.
Measured: Baseline; 15, 30, 45, and 60 minutes post-administration
Respiratory Rate
Measurement of respiratory rate recorded at baseline, 15, 30, 45, and 60 minutes post-administration.
Measured: Baseline; 15, 30, 45, and 60 minutes post-administration
Systolic Blood Pressure
Measurement of systolic blood pressure recorded at baseline, 15, 30, 45, and 60 minutes post-administration.
Measured: Baseline; 15, 30, 45, and 60 minutes post-administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start1 Jan 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Chest PainStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Yichang Humanwell Pharmaceutical Co., Ltd., China
- Responsible party
- Principal investigator, Hao Sun, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06949059
- Sponsor's protocol ID
- 2024-320-03
- Status last verified
- Nov 2025
- First submitted
- 14 Apr 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Acetaminophen Versus Intravenous Hydromorphone for the Treatment of Acute Pain: A Single-Center, Prospective, Single-Arm Study
- ClinicalTrials.gov ID
- NCT06949059
- Acronym / sponsor ID
- 2024-320-03
- Conditions
- Acute Chest Pain
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Collaborators
- Yichang Humanwell Pharmaceutical Co., Ltd., China
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 Apr 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.
To observe the efficacy and safety of hydromorphone in the treatment of acute chest pain, and to explore the potential advantages of hydromorphone for analgesia in patients with acute chest pain, so as to provide more theoretical basis for individualized analgesia and rapid recovery in patients with acute chest pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: HydromorphoneHydromorphone 1mg was given intravenously and conventional treatment was performed at the same time. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18-64 years old;
- Gender is not limited;
- Patients with acute chest pain, with the time from pain onset to visit the doctor ≤ 24 days;
- Severe pain that requires the use of opioids to control as determined by emergency physicians;
- Obtain informed consent from the patient or family members.
Key exclusion criteria (9 listed)
- Known allergy to hydromorphone or morphine;
- Systolic blood pressure <100 mmHg, oxygen saturation <95%, pulse less than 60 beats/min;
- Use of acetaminophen or nonsteroidal anti-inflammatory drugs in the past 8 hours;
- Chronic pain, defined as pain lasting for more than 12 weeks;
- Delirium, alcohol withdrawal symptoms or other drug intoxication;
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 |
|---|---|---|
| HydromorphoneHydromorphone 1mg was given intravenously and conventional treatment was performed at the same time. | Drug | Treatment Group |
Primary outcome
Pain Relief at 30 Minutes After Administration
Time frame: 30 minutes post-medication
The difference between the NRS pain score before medication and the NRS pain score at 30 minutes after administration (i.e., NRS_before-NRS_at_30min). A larger value indicates a better analgesic effect.
8 secondary outcomes
NRS Pain Scores Over 60 Minutes
Time frame: 0, 5, 15, 30, 45, and 60 minutes after administration (plus 5 minutes after any additional dose)
Analgesia Success Rate
Time frame: Up to 60 minutes post-administration
Adverse Events Within 60 Minutes
Time frame: 60 minutes post-administration
Total Dose of Rescue Medication
Time frame: 60 minutes post-administration
Blood Drug Concentration
Time frame: Baseline; 2, 6, 12, and 24 hours post-administration
Oxygen Saturation
Time frame: Baseline; 15, 30, 45, and 60 minutes post-administration
Respiratory Rate
Time frame: Baseline; 15, 30, 45, and 60 minutes post-administration
Systolic Blood Pressure
Time frame: Baseline; 15, 30, 45, and 60 minutes post-administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Hydromorphone in people with Acute Chest Pain, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 17 Nov 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hao Sun, MD, PhD (13584017821 ext. 86, haosun_6@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Relief at 30 Minutes After Administration (time frame: 30 minutes post-medication). 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 17 Nov 2025.