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A Study to Evaluate the Efficacy and Safety of HRS4800 Tablets for Postoperative Analgesia After Impacted Teeth Removal Surgery.

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Hengrui Medicine

Status and phase

Completed
Phase 2

Conditions

Pain

Treatments

Drug: HRS4800 tablets
Drug: Placebo tablets

Study type

Interventional

Funder types

Industry

Identifiers

NCT05318846
HRS4800-201

Details and patient eligibility

About

The study is being conducted to evaluate the efficacy and safety of HRS4800 tablets for postoperative analgesia after impacted teeth removal surgery.

Enrollment

38 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. 18 to 65 years old.
  2. Scheduled to remove the impacted tooth.
  3. Any NRS score ≥5 within 4 hours after the surgery.
  4. Willing to comply with the study procedures and requirements.
  5. Willing and able to provide written informed consent for this study.

Exclusion criteria

  1. Subjects who had used other drugs that affect the analgesic effect.
  2. Subjects who have infection or other complications on the planned oral surgical site.
  3. Subjects with uncontrolled hypertension or hypotension.
  4. Subjects with severe cardiovascular and cerebrovascular diseases.
  5. Subjects with severe gastrointestinal disease.
  6. Subjects with a history of drug or alcohol abuse.
  7. Subjects with significant abnormal electrocardiogram.
  8. Subjects with significant abnormal laboratory value.
  9. Subject who were allergic to the study drug and ingredients.
  10. Pregnancy, lactation or having recent pregnant plan.
  11. Subjects who participated in other clinical research study 30 days before entering this study.
  12. Other conditions unsuitable for participation in the study.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

38 participants in 2 patient groups, including a placebo group

Treatment group A
Experimental group
Treatment:
Drug: HRS4800 tablets
Treatment group B
Placebo Comparator group
Treatment:
Drug: Placebo tablets

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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