Trial Outcomes & Findings for Study to Assess the Safety and Efficacy of Etoricoxib Versus Ibuprofen in the Treatment of Dysmenorrhea (MK-0663-145 AM1) (NCT NCT01462370)

NCT ID: NCT01462370

Last Updated: 2022-02-09

Results Overview

TOPAR6 was calculated by multiplying the pain relief (PR) score (0- to 4-point scale, with 0=None, and 4=Complete for pain relief) at each time point by the duration (in hours) since the preceding time point, and summing these weighted values up to 6 hours post the initial Day 1 dose. The range of TOPAR6 score is 0 to 24, with increasing scores indicating greater pain relief.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 139 participants
• Primary outcome timeframe: Baseline and 0.5, 1, 1.5, 2, 3, 4, 5 and 6 hours
• Results posted on: 2022-02-09

Participant Flow

Participant milestones

Measure	Etoricoxib 120 mg/ Ibuprofen Up to 2400 mg Etoricoxib 120 mg tablet given orally or one dose in menstrual cycle 1. In menstrual cycle 2, ibuprofen was administered at a dose of 600 mg every 4 hours as needed up to 2400 mg/day.	Ibuprofen Up to 2400 mg / Etoricoxib 120 mg Ibuprofen 600 mg given orally up to for times a day as needed for a maximum of 2400 mg/day in menstrual cyle 1. In menstrual cycle 2, etoricoxib 120 mg ws given orally for one dose.
Overall Study STARTED	69	70
Overall Study COMPLETED	68	65
Overall Study NOT COMPLETED	1	5

Reasons for withdrawal

Measure	Etoricoxib 120 mg/ Ibuprofen Up to 2400 mg Etoricoxib 120 mg tablet given orally or one dose in menstrual cycle 1. In menstrual cycle 2, ibuprofen was administered at a dose of 600 mg every 4 hours as needed up to 2400 mg/day.	Ibuprofen Up to 2400 mg / Etoricoxib 120 mg Ibuprofen 600 mg given orally up to for times a day as needed for a maximum of 2400 mg/day in menstrual cyle 1. In menstrual cycle 2, etoricoxib 120 mg ws given orally for one dose.
Overall Study Lack of Qualifying Event	1	1
Overall Study Physician Decision	0	1
Overall Study Withdrawal by Subject	0	3

Baseline Characteristics

Study to Assess the Safety and Efficacy of Etoricoxib Versus Ibuprofen in the Treatment of Dysmenorrhea (MK-0663-145 AM1)

Baseline characteristics by cohort

Measure	All Randomized Participants n=139 Participants All participants randomized into the study.
Age, Customized <=20 years	14 Participants n=5 Participants
Age, Customized 21-29 years	118 Participants n=5 Participants
Age, Customized >=30 years	7 Participants n=5 Participants
Sex: Female, Male Female	139 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 0.5, 1, 1.5, 2, 3, 4, 5 and 6 hours

Population: The population consisted of all participants that received at least one dose of study treatment and had at least one TOPAR6 observation up to 6 hours post initial dose of study medication.

TOPAR6 was calculated by multiplying the pain relief (PR) score (0- to 4-point scale, with 0=None, and 4=Complete for pain relief) at each time point by the duration (in hours) since the preceding time point, and summing these weighted values up to 6 hours post the initial Day 1 dose. The range of TOPAR6 score is 0 to 24, with increasing scores indicating greater pain relief.

Outcome measures

Measure	Etoricoxib 120 mg n=130 Participants Etoricoxib 120 mg tablet given orally for one dose.	Ibuprofen up to 2400 mg n=130 Participants Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
Total Pain Relief Score Over the First 6 Hours (TOPAR6) After the Initial Dose	17.38 Score on a Scale Standard Error 0.37	16.49 Score on a Scale Standard Error 0.37

SECONDARY outcome

Timeframe: Baseline and 0.5, 1, 1.5, 2, 3, 4, 5 and 6 hours

Population: The population consisted of all participants that received at least one dose of study treatment, had at least one SPID6 observation up to 6 hours post initial dose of study medication, and had a baseline measurement.

The Pain Intensity Difference (PID) score is the difference between the baseline pain intensity (PI) score and the PI score recorded at each time point post initial dose, as calculated by subtracting the pain intensity at each of the subsequent time points from the baseline pain intensity score; therefore, it is on a -1 to 3 scale, with a large value representing a greater treatment effect. SPID6 is derived by multiplying the PID score at each time point by the duration (in hours) since the preceding time point, and summing these weighted values up to 6 hours and it is on a scale of -6 to 18.

Outcome measures

Measure	Etoricoxib 120 mg n=130 Participants Etoricoxib 120 mg tablet given orally for one dose.	Ibuprofen up to 2400 mg n=130 Participants Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
Sum of Pain Intensity Difference Scores Over the 6-Hour Time Period (SPID6)	9.48 Score on a Scale Standard Error 0.58	9.27 Score on a Scale Standard Error 0.58

SECONDARY outcome

Timeframe: 6 hours

Population: The population consisted of all participants that received at least one dose of study treatment and had a GLOBAL6 observation at 6 hours post initial dose of study medication.

The GLOBAL6 was recorded by the participant at 6 hours (or at the time of rescue medication use) after taking the first dose of study medication. The GLOBAL6 uses a pain relief scale of 0 to 4, where 0 = poor pain relief, 1 = fair pain relief, 2 = good pain relief, 3 = very good pain relief, and 4 = excellent pain relief.

Outcome measures

Measure	Etoricoxib 120 mg n=129 Participants Etoricoxib 120 mg tablet given orally for one dose.	Ibuprofen up to 2400 mg n=129 Participants Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
Mean Participant Global Evaluation of Pain at 6 Hours After the Initial Dose (GLOBAL6)	2.50 Score on a Scale Standard Error 0.08	2.24 Score on a Scale Standard Error 0.08

SECONDARY outcome

Timeframe: 24 hours

Population: The population consisted of all participants that received at least one dose of study treatment had a GLOBAL24 observation at 24 hours post initial dose of study medication.

The GLOBAL24 was recorded by the participant at 24 hours (or at the time of rescue medication use) after taking the first dose of study medication. The GLOBAL24 uses a pain relief scale of 0 to 4, where 0 = poor pain relief, 1 = fair pain relief, 2 = good pain relief, 3 = very good pain relief, and 4 = excellent pain relief.

Outcome measures

Measure	Etoricoxib 120 mg n=129 Participants Etoricoxib 120 mg tablet given orally for one dose.	Ibuprofen up to 2400 mg n=129 Participants Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
Mean Participant Global Evaluation of Pain at 24 Hours After the Initial Dose (GLOBAL24)	2.65 Score on a Scale Standard Error 0.08	2.29 Score on a Scale Standard Error 0.08

SECONDARY outcome

Timeframe: Baseline and 6 hours

Population: The population consisted of all participants that received at least one dose of study treatment, had an observation at 6 hours post initial dose of study medication, and had a baseline measurement.

The time to a change from baseline in pain intensity score of >=1 unit on the pain intensity scale was calculated. The pain intensity scale rates participant pain on a scale of -1 to 3, with larger values associated with greater treatment effect.

Outcome measures

Measure	Etoricoxib 120 mg n=130 Participants Etoricoxib 120 mg tablet given orally for one dose.	Ibuprofen up to 2400 mg n=130 Participants Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
Mean Time to >=1 Unit Improvement From Baseline in Pain Intensity During the 6 Hours After the Initial Dose	1.0 Hours Interval 1.0 to 1.5	1.5 Hours Interval 1.0 to 1.5

SECONDARY outcome

Timeframe: Baseline and 0.5, 1, 1.5, 2, 3, 4, 5 and 6 hours

Population: The population consisted of all participants that received at least one dose of study treatment and had a PID observation at up to 6 hours post initial dose of study medication.

Peak PID during the 6 hours post initial dose is defined as the maximum PID score recorded during first 6 hours after the initial dose of study medication. PID is evaluated on a scale of -1 to 3, with larger values representing a greater treatment effect.

Outcome measures

Measure	Etoricoxib 120 mg n=130 Participants Etoricoxib 120 mg tablet given orally for one dose.	Ibuprofen up to 2400 mg n=130 Participants Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
Peak Pain Intensity Difference (PID) During the 6 Hours After the Initial Dose	2.2 Score on a Scale Standard Error 0.4	2.1 Score on a Scale Standard Error 0.4

SECONDARY outcome

Timeframe: Up to 6 hours

Population: The population consisted of all participants that received at least one dose of study treatment and had at least one Peak PR observation up to 6 hours post initial dose of study medication.

Peak PR during the 6 hours post initial dose is defined as the maximum PR score

recorded during the first 6 hours after the initial dose of study medication. PR is recorded on a scale of 0 to 4, with 0 = no pain relief, 1 = little pain relief, 2 = some pain relief, 3 = a lot of pain relief, and 4 = complete pain relief.

Outcome measures

Measure	Etoricoxib 120 mg n=130 Participants Etoricoxib 120 mg tablet given orally for one dose.	Ibuprofen up to 2400 mg n=130 Participants Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
Peak Pain Relief (Peak PR) During the 6 Hours After the Initial Dose	3.70 Score on a Scale Standard Error 0.06	3.52 Score on a Scale Standard Error 0.06

SECONDARY outcome

Timeframe: 24 Hours

Population: Due to the low number of participants requiring rescue medication use, the time to rescue medication use was not calculated.

Acetaminophen 250 mg, isopropylantipyrine 150 mg and anhydrous caffeine 50 mg (Saridon) was provided to each participant as rescue medication. Participants were permitted to take 2 tablets at a time and up to 3 doses within 24 hours of dosing of study drug for rescue purposes.

Outcome measures

Measure	Etoricoxib 120 mg n=130 Participants Etoricoxib 120 mg tablet given orally for one dose.	Ibuprofen up to 2400 mg n=130 Participants Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
Number of Participants Using Rescue Medication 24 Hours After the Initial Dose	1 Participants	4 Participants

SECONDARY outcome

Timeframe: Baseline and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 and 12 hours

Population: The population consisted of all participants that received at least one dose of study treatment and had at least one PID observation at up to 12 hours post initial dose of study medication.

PID during the 12 hours following the initial dose is defined as the maximum PID score recorded during first 12 hours after the initial dose of study medication. PID is evaluated on a scale from 0 to 3, with 0 = no pain, 1 = slight pain, 2 = moderate pain, and 3 = severe pain.

Outcome measures

Measure	Etoricoxib 120 mg n=130 Participants Etoricoxib 120 mg tablet given orally for one dose.	Ibuprofen up to 2400 mg n=129 Participants Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
PID at Up to 12 Hours Following the Initial Dose	2.28 Score on a Scale Standard Error 0.04	2.07 Score on a Scale Standard Error 0.04

SECONDARY outcome

Timeframe: Up to 12 hours

Population: The population consisted of all participants that received at least one dose of study treatment and had at least one PR observation up to 12 hours post initial dose of study medication.

PR during the 12 hours following the initial dose is defined as the maximum PR score recorded during the first 12 hours after the initial dose of study medication. PR is evaluated on a scale of 0 to 4, with 0 = no pain relief, 1= a little pain relief, 2 = some pain relief, 3 = a lot of pain relief, and 4 = complete pain relief.

Outcome measures

Measure	Etoricoxib 120 mg n=130 Participants Etoricoxib 120 mg tablet given orally for one dose.	Ibuprofen up to 2400 mg n=129 Participants Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
PR at Up to 12 Hours Following the Initial Dose	3.73 Score on a Scale Standard Error 0.07	3.45 Score on a Scale Standard Error 0.07

SECONDARY outcome

Timeframe: Baseline and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 20 and 24 hours

Population: The population consisted of all participants that received at least one dose of study treatment and had at least one PID observation up to 24 hours post initial dose of study medication.

PID during the 24 hours following the initial dose is defined as the maximum PID score recorded during first 24 hours after the initial dose of study medication. PID is evaluated on a scale from 0 to 3, with 0 = no pain, 1 = slight pain, 2 = moderate pain, and 3 = severe pain.

Outcome measures

Measure	Etoricoxib 120 mg n=130 Participants Etoricoxib 120 mg tablet given orally for one dose.	Ibuprofen up to 2400 mg n=130 Participants Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
PID at Up to 24 Hours Following the Initial Dose	2.36 Score on a Scale Standard Error 0.04	2.25 Score on a Scale Standard Error 0.04

SECONDARY outcome

Timeframe: Up to 24 hours

Population: The population consisted of all participants that received at least one dose of study treatment and had at least one PR observation at up to 24 hours post initial dose of study medication.

PR during the 24 hours following the initial dose is defined as the maximum PR score recorded during the first 24 hours after the initial dose of study medication. PR is evaluated on a scale of 0 to 4, with 0 = no pain relief, 1= a little pain relief, 2 = some pain relief, 3 = a lot of pain relief, and 4 = complete pain relief.

Outcome measures

Measure	Etoricoxib 120 mg n=130 Participants Etoricoxib 120 mg tablet given orally for one dose.	Ibuprofen up to 2400 mg n=130 Participants Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
PR at Up to 24 Hours Following the Initial Dose	3.88 Score on a Scale Standard Error 0.07	3.62 Score on a Scale Standard Error 0.07

SECONDARY outcome

Timeframe: 6 hours

Population: The population consisted of all participants that received at least one dose of study treatment and completed the assessment at 6 hours post initial dose of study medication.

At 6 hours following the initial dose. participants were asked to rate their perception of pain control as poor, fair, good, very good, or excellent. The number of participants that reported good, very good, or excellent pain control at 6 hours post initial dose were summed.

Outcome measures

Measure	Etoricoxib 120 mg n=129 Participants Etoricoxib 120 mg tablet given orally for one dose.	Ibuprofen up to 2400 mg n=129 Participants Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
Number of Participants With a Global Evaluation of Study Medication of Good, Very Good, or Excellent at 6 Hours After the Initial Dose	111 Participants	103 Participants

SECONDARY outcome

Timeframe: 24 Hours

Population: The population consisted of all participants that received at least one dose of study treatment and completed the assessment at 24 hours post initial dose of study medication

At 24 hours following the initial dose of study medication, participants were asked to rate their perception of pain control as poor, fair, good, very good, or excellent. The number of participants that reported good, very good, or excellent pain control at 24 hours post initial dose were summed.

Outcome measures

Measure	Etoricoxib 120 mg n=129 Participants Etoricoxib 120 mg tablet given orally for one dose.	Ibuprofen up to 2400 mg n=129 Participants Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
Number of Participants With a Global Evaluation of Study Medication of Good, Very Good, or Excellent at 24 Hours After the Initial Dose	113 Participants	101 Participants

Adverse Events

Etoricoxib 120 mg / Ibuprofen up to 2400 mg/Daily

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ibuprofen up to 2400 mg / Etoricoxib 120 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Vice President, Late Stage Development Group Leader

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission. The sponsor review can be expedited to meet publication timelines.
• Publication restrictions are in place

Restriction type: OTHER