A Study to Evaluate the Efficacy and Safety of HR18042 Tablets for Postoperative Analgesia After Impacted Teeth Removal Surgery.

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Hengrui Medicine

Status and phase

Enrolling
Phase 2

Conditions

Pain

Treatments

Drug: Tramadol hydrochloride SR Tablets
Drug: HR18042 tablets
Drug: Placebos

Study type

Interventional

Funder types

Industry

Identifiers

NCT05470075
HR18042-202

Details and patient eligibility

About

This is a multicenter, randomized, double-blind, dose finding, parallel controlled with active drug and placebo, phase II clinical trial, and the purpose of the study is to evaluate the efficacy and safety of HR18042 tablets for postoperative analgesia after impacted teeth removal surgery.

Enrollment

180 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age ≥ 18 years old.
  • Scheduled to remove the impacted tooth.
  • Any NRS score reaches the inclusion criteria within 4 hours after the surgery.
  • Willing to comply with the study procedures and requirements.
  • Willing and able to provide written informed consent for this study.

Exclusion criteria

  • Subjects who have used other drugs that have the analgesic effect.
  • Subjects who have used any drug that affect the efficacy and safety of study drug.
  • Subjects who have infection or other complications on the planned oral surgical site.
  • Subjects with hypertension or hypotension during screening period.
  • Subjects with severe cardiovascular and cerebrovascular diseases.
  • Subjects with severe gastrointestinal disease.
  • Subjects with Respiratory diseases.
  • Subjects with a history of seizure, or drug or alcohol abuse.
  • Subjects with significant abnormal electrocardiogram result.
  • Subjects with significant abnormal laboratory value.
  • Subject who were allergic to the study drug and ingredients.
  • Pregnancy, lactation or having recent pregnant plan.
  • Subjects who participated in other clinical research study 30 days before entering this study.
  • Other conditions unsuitable for participation in the study.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

180 participants in 5 patient groups, including a placebo group

Experimental A: HR18042 175mg
Experimental group
Treatment:
Drug: HR18042 tablets
Experimental B: HR18042 225mg
Experimental group
Treatment:
Drug: HR18042 tablets
Experimental C: HR18042 275mg
Experimental group
Treatment:
Drug: HR18042 tablets
Active Drug Comparator:Tramadol hydrochloride SR Tablets 100mg
Active Comparator group
Treatment:
Drug: Tramadol hydrochloride SR Tablets
Placebo Comparator: Placebos match to HR18042 and Tramadol hydrochloride SR Tablets
Placebo Comparator group
Treatment:
Drug: Placebos

Trial contacts and locations

1

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Central trial contact

Qin Liu

Data sourced from clinicaltrials.gov

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