Back to resultsA Study to Evaluate the Efficacy and Safety of HR18042 Tablets in the Treatment of Postoperative Pain of Impacted Tooth.
Primary Purpose
Moderate to Severe Acute Pain
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
HR18042
HR18042
HR18042
Tramadol hydrochloride ER
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Moderate to Severe Acute Pain
Eligibility Criteria
Inclusion Criteria:
- 18 to 75 years old.
- Subjects must have a plan of extraction of impacted tooth.
- Subjects with moderate to severe pain (VAS score ≥ 50mm).This must be measured within a maximum of 4 hours after the end of extraction of impacted tooth.
- weight at least 45kg,and no more than 100kg.
- If a female is of child-bearing potential, she must be using highly effective methods of contraception throughout the study.
- Willingness to comply with the study procedures and requirements.
- willing and able to provide written informed consent for this study.
Exclusion Criteria:
- any analgesic medication other than preoperative or intraoperative anaesthetic agents within 12h before taking trial medication medication
- a longacting NSAID within 4 days,or a shortacting NSAID within 1 days prior to dosing.
- any anti-depressive medication, selective serotonin reuptake inhibitors (SSRIs), diet pills et.al. with 30 days of study entry.
- Oral surgical site combined with infection.
- Severe cardiovascular and cerebrovascular diseases.
- Severe gastrointestinal disease.
- had a history of seizures or drug or alcohol abuse.
- uncontrolled hypertension.
- significant abnormal electrocardiogram
- significant abnormal laboratory value.
- Allergic to the study drug and ingredients.
- Pregnancy, lactation or recent Pregnant plan;
- Subjects who participated in a clinical research study involving an experimental drug before 30 days of study entry.
- other conditions unsuitable for participation in the study.
Sites / Locations
- West China Hospital of Stomatology Sichuan University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
HR18042 100mg
HR18042 125mg
HR18042 200mg
Tramadol hydrochloride ER 100mg
Placebo to match HR18042 and Tramadol hydrochloride ER
Arm Description
Outcomes
Primary Outcome Measures
the Sum of Pain Intensity Differences（SPID）
SPID is derived as the weighted Sum of Pain Intensity Differences (baseline pain - current pain), measured at different time points via the PI-VAS. Time between two consecutive measurements will be used for weighting. Larger values indicate larger pain relief.
Secondary Outcome Measures
the Sum of Pain Intensity Differences（SPID）
the Sum of Pain Intensity Differences（SPID）
Pain Intensity Differences（PID）
Include pain intensity differences(PIDs) from baseline at each time point. measured at different time points via the PI-VAS.
Pain relief（PAR）
pain relief (PAR) on a 5-point Likert scale (0, none, 1, a little, 2, some,3, a lot, 4, complete).
the Sum of Pain relief Differences（SPAR）
SPAR is derived as the weighted Sum of Pain relief, measured at different time points via the 5-point Likert scale. Time between two consecutive measurements will be used for weighting. Larger values indicate larger pain relief.
the Sum of Pain relief Differences（SPAR）
the Sum of Pain relief Differences（SPAR）.
Subject who reaches a 30% reduction in pain intensity from baseline
Subject who reaches a 50% reduction in pain intensity from baseline
time to perceptible pain relief
time to meaningful pain relief
Patients used one stopwatch to record the time to 'perceptible' PAR and another stopwatch for the time to'meaningful' PAR.Patients started timing upon intake of study medication and stopped one stopwatch at the onset of perceptible PAR and another upon achieving meaningful PAR.
Time to first use of rescue medication
Proportion of subjects who take of at least 1 dose of rescue medication
Subject's overall assessment of study medication
Patients made an overall assessment of the study medication using a verbal rating scale (excellent, verygood, good, fair, poor).
Full Information
NCT ID
NCT04812860
First Posted
March 17, 2021
Last Updated
March 22, 2021
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04812860
Brief Title
A Study to Evaluate the Efficacy and Safety of HR18042 Tablets in the Treatment of Postoperative Pain of Impacted Tooth.
Official Title
A Multicenter,Randomized, Double-blind, Dose Ranging , Active- and Placebo-controlled, Parallel Groups, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HR18042 Tablets for the Treatment of Postoperative Pain of Impacted Tooth.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 8, 2020 (Actual)
Primary Completion Date
January 25, 2021 (Actual)
Study Completion Date
April 23, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study was to evaluate the Efficacy and safety of HR18042 tablets for the Treatment of Post-surgical Pain After extraction of impacted tooth, find the optimal dose.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate to Severe Acute Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
A Multicenter,randomized, double-blind, Dose Ranging , controlled with active treatment and placebo, parallel groups, Phase II clinical trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
187 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HR18042 100mg
Arm Type
Experimental
Arm Title
HR18042 125mg
Arm Type
Experimental
Arm Title
HR18042 200mg
Arm Type
Experimental
Arm Title
Tramadol hydrochloride ER 100mg
Arm Type
Active Comparator
Arm Title
Placebo to match HR18042 and Tramadol hydrochloride ER
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
HR18042
Intervention Description
Tablet, Dosing frequency: once daily, Route of administration: oral
Intervention Type
Drug
Intervention Name(s)
HR18042
Intervention Description
Tablet,Dosing frequency: once daily, Route of administration: oral
Intervention Type
Drug
Intervention Name(s)
HR18042
Intervention Description
Tablet,Dosing frequency: once daily, Route of administration: oral
Intervention Type
Drug
Intervention Name(s)
Tramadol hydrochloride ER
Intervention Description
Tablet,Dosing frequency: once daily, Route of administration: oral
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablet,Dosing frequency: once daily, Route of administration: oral
Primary Outcome Measure Information:
Title
the Sum of Pain Intensity Differences（SPID）
Description
SPID is derived as the weighted Sum of Pain Intensity Differences (baseline pain - current pain), measured at different time points via the PI-VAS. Time between two consecutive measurements will be used for weighting. Larger values indicate larger pain relief.
Time Frame
0-8hours
Secondary Outcome Measure Information:
Title
the Sum of Pain Intensity Differences（SPID）
Time Frame
0-4hours
Title
the Sum of Pain Intensity Differences（SPID）
Time Frame
0-12hours
Title
Pain Intensity Differences（PID）
Description
Include pain intensity differences(PIDs) from baseline at each time point. measured at different time points via the PI-VAS.
Time Frame
0-12hours
Title
Pain relief（PAR）
Description
pain relief (PAR) on a 5-point Likert scale (0, none, 1, a little, 2, some,3, a lot, 4, complete).
Time Frame
0-12hours
Title
the Sum of Pain relief Differences（SPAR）
Description
SPAR is derived as the weighted Sum of Pain relief, measured at different time points via the 5-point Likert scale. Time between two consecutive measurements will be used for weighting. Larger values indicate larger pain relief.
Time Frame
0-4hours
Title
the Sum of Pain relief Differences（SPAR）
Time Frame
0-8hours
Title
the Sum of Pain relief Differences（SPAR）.
Time Frame
0-12hours
Title
Subject who reaches a 30% reduction in pain intensity from baseline
Time Frame
4hours、8hours、12hours
Title
Subject who reaches a 50% reduction in pain intensity from baseline
Time Frame
4hours、8hours、12hours
Title
time to perceptible pain relief
Time Frame
0-12hours
Title
time to meaningful pain relief
Description
Patients used one stopwatch to record the time to 'perceptible' PAR and another stopwatch for the time to'meaningful' PAR.Patients started timing upon intake of study medication and stopped one stopwatch at the onset of perceptible PAR and another upon achieving meaningful PAR.
Time Frame
0-12hours
Title
Time to first use of rescue medication
Time Frame
0-12hours
Title
Proportion of subjects who take of at least 1 dose of rescue medication
Time Frame
0-12hours
Title
Subject's overall assessment of study medication
Description
Patients made an overall assessment of the study medication using a verbal rating scale (excellent, verygood, good, fair, poor).
Time Frame
12hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 to 75 years old.
Subjects must have a plan of extraction of impacted tooth.
Subjects with moderate to severe pain (VAS score ≥ 50mm).This must be measured within a maximum of 4 hours after the end of extraction of impacted tooth.
weight at least 45kg,and no more than 100kg.
If a female is of child-bearing potential, she must be using highly effective methods of contraception throughout the study.
Willingness to comply with the study procedures and requirements.
willing and able to provide written informed consent for this study.
Exclusion Criteria:
any analgesic medication other than preoperative or intraoperative anaesthetic agents within 12h before taking trial medication medication
a longacting NSAID within 4 days,or a shortacting NSAID within 1 days prior to dosing.
any anti-depressive medication, selective serotonin reuptake inhibitors (SSRIs), diet pills et.al. with 30 days of study entry.
Oral surgical site combined with infection.
Severe cardiovascular and cerebrovascular diseases.
Severe gastrointestinal disease.
had a history of seizures or drug or alcohol abuse.
uncontrolled hypertension.
significant abnormal electrocardiogram
significant abnormal laboratory value.
Allergic to the study drug and ingredients.
Pregnancy, lactation or recent Pregnant plan;
Subjects who participated in a clinical research study involving an experimental drug before 30 days of study entry.
other conditions unsuitable for participation in the study.
Facility Information:
Facility Name
West China Hospital of Stomatology Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Efficacy and Safety of HR18042 Tablets in the Treatment of Postoperative Pain of Impacted Tooth.
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