Health TrialsbyHealthPanel

A Clinical Trial Evaluating the Efficacy and Safety of HSK55718 in Patients for Postoperative Pain Treatment in Abdominal Surgery

ConditionPain After Surgery
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHaisco Pharmaceutical Group Co., Ltd.

About this trial

This is a multi-center, randomized, double-blind, double-dummy, placebo/active-controlled study. 200 subjects undergoing abdominal surgery under general anesthesia are planned to be enrolled and randomized into the HSK55718 group, morphine group, and placebo group.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years old, regardless of gender;

18 kg/m2≤BMI≤30 kg/m2;

American Society of Anesthesiologists (ASA) gradeⅰ-ⅲ;

Accept abdominal surgery under general anesthesia;

Disqualifiers

A history of cardiovascular, respiratory, neurological, or psychiatric diseases that meet the protocol-defined exclusion criteria.

Clinically significant abnormalities in laboratory tests during the screening period.

A history of severe drug allergy or known allergy to the investigational drug.

Continuous use of opioid analgesics for more than 10 days for any reason within 3 months prior to randomization.

Trial design

Design model

Parallel

Treatments tested in this trial

  • HSK55718 dose level1

    Drug

    Patients administrated with HSK55718 at dose level 1

  • HSK55718 dose level2

    Drug

    Patients administrated with HSK55718 at dose level 2

  • HSK55718 dose level 3

    Drug

    Patients administrated with HSK55718 at dose level 3

  • Placebo control

    Drug

    Patients administrated with placebo

  • morphine

    Drug

    Patients administrated with morphine

Treatment groups

200 Participants
are divided into 5 treatment groups
Group A: HSK55718 dose level1Experimental treatment 1 intervention
Group B: HSK55718 dose level2Experimental treatment 1 intervention
Group C: HSK55718 dose level 3Experimental treatment 1 intervention
Group D: Placebo controlPlacebo comparator 1 intervention
Group E: morphineActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Sum of Pain Intensity Differences (SPID)

Time frame
24 hours

Secondary outcomes

1

Sum of Pain Intensity Differences (SPID) in other time frame

Time frame
0-12 hours, 12-24 hours, 24-48 hours, 48 hours
2

Number of times rescue analgesic medications were administered.

Time frame
48 hours
3

Time to Pain Relief

Time frame
0-48 hours
4

Postoperative Analgesia Satisfaction Score

Time frame
48 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Haisco Pharmaceutical Group Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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