Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT04811053
NCT04811053CompletedPhase 2

A Phase Ⅱ, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of HR021618 in the Treatment of Moderate to Severe Pain After Abdominal Surgery

Jiangsu HengRui Medicine Co., Ltd.1 site in 1 country60 target enrollmentStarted: April 12, 2021Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
60
Locations
1
Primary Endpoint
AUC48
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The study is being conducted to evaluate the efficacy and safety of HR021618 in the treatment of moderate to severe pain after abdominal surgery.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Able and willing to provide a written informed consent
  • •Subjects requiring elective general anesthesia abdominal surgery
  • •Male or female
  • •Meet BMI standard
  • •Conform to the ASA Physical Status Classification

Exclusion Criteria

  • •Subjects with a history of abdominal surgery
  • •Subjects had hemorrhagic disorders
  • •Subjects had cardiac, serious hepatic or renal, cardiovascular or cerebrovascular, metabolic, psychiatric disorders, chronic pain, or malignant tumors
  • •Subjects with poor blood pressure control after medication
  • •Abnormal QTc
  • •Abnormal random blood glucose
  • •Abnormal values in the laboratory
  • •Allergic to meloxicam or any excipient of HR021618, aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs) or to any peri- or postoperative medications used in this study
  • •Use other drugs that affect the analgesic effect before randomization, and the time from the last use to randomization is shorter than 5 half-lives
  • •Pregnant or nursing women
  • •No birth control during the specified period of time
  • •Participated in clinical trials of other drugs (received experimental drugs)
  • •The inestigators determined that other conditions were inappropriate for participation in this clinical trial

Arms & Interventions

Treatment group A

Experimental

Intervention: HR021618 (Drug)

Treatment group B

Placebo Comparator

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

AUC48

Time Frame: 48 hours after recovery from anesthesia] Area under the pain intensity-time curve.

Area under the pain intensity-time curve.

Secondary Outcomes

  • Anesthesiologist satisfaction rating(48 hours after recovery from anesthesia)
  • Total consumption of morphine over 0-48, 0-24, 24-48 hours(48 hours after recovery from anesthesia)
  • Time of the first dose of rescue analgesia(48 hours after recovery from anesthesia)
  • Proportion of subjects receiving rescue analgesia(48 hours after recovery from anesthesia)
  • Subjects' satisfaction rating(48 hours after recovery from anesthesia)
  • Frequency of doses of rescue analgesia(48 hours after recovery from anesthesia)
  • AUC3, AUC24, AUC15-21, AUC18-24, AUC24-28, AUC39-45, AUC42-48(48 hours after recovery from anesthesia)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials

Unknown
Phase 2
A Trial of HR021618 in Postsurgical Pain ManagementPostsurgical Pain Management
NCT04699175Jiangsu HengRui Medicine Co., Ltd.108
Recruiting
Phase 2
A Trial of SHR-A2102 for Treatment of Advanced Gynecological MalignancyAdvanced Gynecological Malignancy
NCT06654440Shanghai Hengrui Pharmaceutical Co., Ltd.100
Completed
Phase 2
Study to Evaluate Efficacy, Safety and Tolerability of HM15211(Efocipegtrutide) in SubjectsNASH - Nonalcoholic Steatohepatitis
NCT04505436Hanmi Pharmaceutical Company Limited215
Completed
Phase 2
CODY: A Study Evaluating The Safety And Efficacy Of QTORIN 3.9% Sirolimus Topical Gel For The Prevention Of Basal Cell Carcinomas (BCCs) In Patients With Gorlin SyndromeBCCs in Gorlin Syndrome Patients
NCT04893486Palvella Therapeutics, Inc.73
Completed
Phase 2
Phase II Trial to Evaluate the Efficacy and Safety of HM61713 as the 1st-line NSCLC Anticancer TherapyNon Small Cell Lung Cancer
NCT02444819Hanmi Pharmaceutical Company Limited33