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

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

About this trial

This is a multi-center, randomized, double-blind, placebo/active-controlled study. 200 subjects undergoing orthopedic 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

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • HSK55718 dose level 1

    Drug

    Patients administrated with HSK55718 at dose level 1

  • HSK55718 dose level 2

    Drug

    Patients administrated with HSK55718 at dose level 2

  • HSK55718 dose level 3

    Drug

    Patients administrated with HSK55718 at dose level 3

  • placebo

    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 level 2Experimental 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
48hours

Secondary outcomes

1

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

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

Locations

This trial has no locations.

Sponsors and contacts

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

Haisco Pharmaceutical Group Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: