Postoperative PainPhase 2/3NCT07709598
Evaluate the Safety and Efficacy of HL-1186 Tablet for Postoperative Analgesia in Abdominal Surgery
A Phase 2/3 study testing HL-1186 and Oxycodone-Acetaminophen in people with Postoperative Pain, run by Shanghai Huilun Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This clinical trial is a multiple-center, randomized, double-blind, placebo- and active-controlled parallel-group Phase II/III clinical trial, to evaluate the efficacy and safety of HL-1186 Tablets for Postoperative Analgesia in Abdominal Surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- HL-1186 and Oxycodone-Acetaminophen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 330 participants
- Where
- 1 siteChina
- Study dates
- 11 May 2026to Dec 2026
- Phase
- Phase 2/3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old ≤ age ≤ 75 years old, gender is not limited.
- 18 kg/m2 ≤ Body Mass Index (BMI) ≤ 30kg/m2.
- Scheduled to undergo abdominal surgery under general anesthesia, with expected moderate-to-severe postoperative pain intensity.
- Able to understand the research process and the use of pain scales, and communicate effectively with researchers.
- After surgery completion, the participant is judged by the investigator to be awake and has a resting NRS score ≥ 4.
Who cannot join
- Previous surgery on the same site that may affect pain perception at the surgical site.
- Paresthesia or other pain that may affect postoperative pain evaluation or scale assessment.
- Neuropsychological disorders that may affect postoperative pain evaluation or scale assessment.
- Unstable angina, myocardial infarction, severe arrhythmia, NYHA cardiac function class ≥ III, or recurrent asthma attacks, etc., deemed unsuitable for inclusion by the investigator.
- Poorly controlled hypertension.
- Sleep apnea syndrome, or the presence of a difficult airway as assessed by the investigator.
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- Known allergy to any component of the investigational drug(s), to perioperative (from induction of anesthesia to completion of surgery) anesthetic/analgesic/antiemetic drugs, or a history of allergy to ≥ 3 substances.
- Positive for human immunodeficiency virus (HIV) antibody; positive for Treponema pallidum antibody and positive toluidine red unheated serum test (TRUST); positive for hepatitis B surface antigen (HBsAg) with detectable HBV-DNA; or positive for hepatitis C virus (HCV) antibody.
- Women who are pregnant or breastfeeding (within 1 year after delivery).
- Participation in another drug or medical device trial within 1 month before screening, or currently participating in another clinical trial receiving investigational intervention.
- Any other condition considered unsuitable for participation by the investigator.
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
Sichuan Provincial People's Hospital
Chengdu, Sichuan
Sichuan Provincial People's Hospital, +86-028-87393401, syyirb@163.com
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Parallel-Group Phase II/III Clinical Trial to Evaluate the Efficacy and Safety of HL-1186 Tablets for Postoperative Analgesia in Abdominal Surgery
This clinical trial is a multiple-center, randomized, double-blind, placebo- and active-controlled parallel-group Phase II/III clinical trial, to evaluate the efficacy and safety of HL-1186 Tablets for Postoperative Analgesia in Abdominal Surgery.
- Conditions
- Postoperative Pain
- Being tested
- HL-1186, HL-1186 placebo, Oxycodone-Acetaminophen, Oxycodone-Acetaminophen Matching 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.
HL-1186Drug
HL-1186 tablet for oral administration.
HL-1186 placeboDrug
HL-1186 placebo tablet for oral administration.
Oxycodone-AcetaminophenDrug
Oxycodone-Acetaminophen for oral adminstration.
Oxycodone-Acetaminophen Matching PlaceboDrug
Oxycodone-Acetaminophen Matching Placebo for oral adminstration.
| Study group | Role | What they receive |
|---|---|---|
| HL-1186 High-Dose Group | Experimental | Participants will be randomized to either the HL-1186 groups, placebo group or active-comparator group, and administer study drug every 6 hours Receives: Drug: HL-1186; Drug: Oxycodone-Acetaminophen Matching Placebo |
| HL-1186 Low-Dose Group | Experimental | Participants will be randomized to either the HL-1186 groups, placebo group or active-comparator group, and administer study drug every 6 hours Receives: Drug: HL-1186; Drug: HL-1186 placebo; Drug: Oxycodone-Acetaminophen Matching Placebo |
| Oxycodone-Acetaminophen Group | Active comparator | Participants will be randomized to either the HL-1186 groups, placebo group or active-comparator group, and administer study drug every 6 hours Receives: Drug: HL-1186 placebo; Drug: Oxycodone-Acetaminophen |
| Placebo Group | Placebo comparator | Participants will be randomized to either the HL-1186 groups, placebo group or active-comparator group, and administer study drug every 6 hours Receives: Drug: HL-1186 placebo; Drug: Oxycodone-Acetaminophen Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
SPID48
SPID48: Time-weighted Sum of the Pain Intensity Difference (SPID) as recorded on an NRS (Numeric Rating Scale, 0 =no pain to 10 =worst possible pain) at rest 0 to 48 hours after the first dose of study drug. The score range was -480 (worst score) to 480 (best score).
Measured: 0 to 48 hours
Secondary outcomes (1)
Number of participants with treatment-related adverse events
Measured: 0-9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start11 May 2026
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Huilun Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07709598
- Sponsor's protocol ID
- PY-HL-1186-AS-301
- Status last verified
- Jul 2026
- First submitted
- 12 Jul 2026
- Last updated
- 16 Jul 2026
- 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 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Parallel-Group Phase II/III Clinical Trial to Evaluate the Efficacy and Safety of HL-1186 Tablets for Postoperative Analgesia in Abdominal Surgery
- ClinicalTrials.gov ID
- NCT07709598
- Acronym / sponsor ID
- PY-HL-1186-AS-301
- Conditions
- Postoperative Pain
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Shanghai Huilun Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 May 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 Jul 2026 (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 clinical trial is a multiple-center, randomized, double-blind, placebo- and active-controlled parallel-group Phase II/III clinical trial, to evaluate the efficacy and safety of HL-1186 Tablets for Postoperative Analgesia in Abdominal Surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HL-1186 High-Dose Group | Experimental | Drug: HL-1186, Drug: Oxycodone-Acetaminophen Matching PlaceboParticipants will be randomized to either the HL-1186 groups, placebo group or active-comparator group, and administer study drug every 6 hours |
| HL-1186 Low-Dose Group | Experimental | Drug: HL-1186, Drug: HL-1186 placebo, Drug: Oxycodone-Acetaminophen Matching PlaceboParticipants will be randomized to either the HL-1186 groups, placebo group or active-comparator group, and administer study drug every 6 hours |
| Oxycodone-Acetaminophen Group | Active comparator | Drug: HL-1186 placebo, Drug: Oxycodone-AcetaminophenParticipants will be randomized to either the HL-1186 groups, placebo group or active-comparator group, and administer study drug every 6 hours |
| Placebo Group | Placebo comparator | Drug: HL-1186 placebo, Drug: Oxycodone-Acetaminophen Matching PlaceboParticipants will be randomized to either the HL-1186 groups, placebo group or active-comparator group, and administer study drug every 6 hours |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years old ≤ age ≤ 75 years old, gender is not limited.
- 18 kg/m2 ≤ Body Mass Index (BMI) ≤ 30kg/m2.
- Scheduled to undergo abdominal surgery under general anesthesia, with expected moderate-to-severe postoperative pain intensity.
- Able to understand the research process and the use of pain scales, and communicate effectively with researchers.
- After surgery completion, the participant is judged by the investigator to be awake and has a resting NRS score ≥ 4.
Key exclusion criteria (11 listed)
- Previous surgery on the same site that may affect pain perception at the surgical site.
- Paresthesia or other pain that may affect postoperative pain evaluation or scale assessment.
- Neuropsychological disorders that may affect postoperative pain evaluation or scale assessment.
- Unstable angina, myocardial infarction, severe arrhythmia, NYHA cardiac function class ≥ III, or recurrent asthma attacks, etc., deemed unsuitable for inclusion by the investigator.
- Poorly controlled hypertension.
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 |
|---|---|---|
| HL-1186HL-1186 tablet for oral administration. | Drug | HL-1186 High-Dose Group, HL-1186 Low-Dose Group |
| HL-1186 placeboHL-1186 placebo tablet for oral administration. | Drug | HL-1186 Low-Dose Group, Oxycodone-Acetaminophen Group, Placebo Group |
| Oxycodone-AcetaminophenOxycodone-Acetaminophen for oral adminstration. | Drug | Oxycodone-Acetaminophen Group |
| Oxycodone-Acetaminophen Matching PlaceboOxycodone-Acetaminophen Matching Placebo for oral adminstration. | Drug | HL-1186 High-Dose Group, HL-1186 Low-Dose Group, Placebo Group |
Primary outcome
SPID48
Time frame: 0 to 48 hours
SPID48: Time-weighted Sum of the Pain Intensity Difference (SPID) as recorded on an NRS (Numeric Rating Scale, 0 =no pain to 10 =worst possible pain) at rest 0 to 48 hours after the first dose of study drug. The score range was -480 (worst score) to 480 (best score).
1 secondary outcome
Number of participants with treatment-related adverse events
Time frame: 0-9 days
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 16 Jul 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.
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 HL-1186 and Oxycodone-Acetaminophen in people with Postoperative Pain, run by Shanghai Huilun Pharmaceutical Co., Ltd. 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 11 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 16 Jul 2026. 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. 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 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?
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 Renhai Yang (021-64311017, clinical_trial@hllife.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SPID48 (time frame: 0 to 48 hours). 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 16 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.