HR021618 in Moderate to Severe Pain After Abdominal Surgery

• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04811053
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 2.6
• Patients Per Site Per Month: 23.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain After Abdominal Surgery	Drug: HR021618; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Parallel AssignmentParallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Apr 12, 2021
• Anticipated Primary Completion Date: Jun 25, 2021
• Anticipated Study Completion Date: Jun 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment group A	Drug: HR021618; Treatment group A: HR021618 injection
Placebo Comparator: Treatment group B	Drug: Placebo; Treatment group B: Saline injection

Outcome Measures

Primary Outcome Measures

1. AUC48 [48 hours after recovery from anesthesia] Area under the pain intensity-time curve.]

   Area under the pain intensity-time curve.

Secondary Outcome Measures

1. Total consumption of morphine over 0-48, 0-24, 24-48 hours [48 hours after recovery from anesthesia]

   Total consumption of morphine after recovery from anesthesia.

2. AUC3, AUC24, AUC15-21, AUC18-24, AUC24-28, AUC39-45, AUC42-48 [48 hours after recovery from anesthesia]

   Area under the pain intensity-time curve.

3. Time of the first dose of rescue analgesia [48 hours after recovery from anesthesia]

   Time of the first dose of rescue analgesia after recovery from anesthesia.

4. Proportion of subjects receiving rescue analgesia [48 hours after recovery from anesthesia]

   Proportion of subjects receiving rescue analgesia after recovery from anesthesia.

5. Frequency of doses of rescue analgesia [48 hours after recovery from anesthesia]

   Frequency of doses of rescue analgesia after recovery from anesthesia.

6. Subjects' satisfaction rating [48 hours after recovery from anesthesia]

   Subjects' satisfaction rating.

7. Anesthesiologist satisfaction rating [48 hours after recovery from anesthesia]

   Anesthesiologist satisfaction rating.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Able and willing to provide a written informed consent

2. Subjects requiring elective general anesthesia abdominal surgery

3. Male or female

4. Meet BMI standard

5. Conform to the ASA Physical Status Classification

Exclusion Criteria:

1. Subjects with a history of abdominal surgery

2. Subjects had hemorrhagic disorders

3. Subjects had cardiac, serious hepatic or renal, cardiovascular or cerebrovascular, metabolic, psychiatric disorders, chronic pain, or malignant tumors

4. Subjects with poor blood pressure control after medication

5. Abnormal QTc

6. Abnormal random blood glucose

7. Abnormal values in the laboratory

8. 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

9. 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

10. Pregnant or nursing women

11. No birth control during the specified period of time

12. Participated in clinical trials of other drugs (received experimental drugs)

13. The inestigators determined that other conditions were inappropriate for participation in this clinical trial

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	West China Hospital, Sichuan University	Chengdu	Sichuan	China	610041

Sponsors and Collaborators

• Jiangsu HengRui Medicine Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04811053
• Other Study ID Numbers: HR021618-203
• First Posted: Mar 23, 2021
• Last Update Posted: Jul 1, 2021
• Last Verified: Mar 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 1, 2021