check_circleStudy Completed

Dysmenorrhea

A Study to Assess Menstrual Cramp Pain Associated with Primary Dysmenorrhea

Trial purpose

The purpose of this study is to compare the maximum single dose of Aleve® (two tablets, equivalent to 440 mg of naproxen sodium) to the maximum single dose of Tylenol Extra Strength (two caplets, equivalent to 1000 mg of acetaminophen) in the treatment of menstrual pain associated with primary dysmenorrhea.

Key Participants Requirements

Sex

Female

Age

15 - 35 Years

Trial summary

Enrollment Goal
201
Trial Dates
April 2018 - September 2018
Phase
Phase 4
Could I Receive a placebo
No
Products
Aleve (Naproxen Sodium, BAY117031)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Radiant Research, Inc.Chandler, 85224, United States
Completed
Synexus US, LP- PlanoPlano, 75234, United States
Completed
Radiant Research, Inc.Dallas, 75234, United States
Completed
Radiant Research, Inc.Pinellas Park, 33781, United States
Completed
Radiant Research, Inc.Cincinnati, 45236, United States
Completed
Radiant Research, Inc.Chicago, 60602, United States
Completed
Radiant Research, Inc.Akron, 44311, United States
Completed
Radiant Research, Inc.Scottsdale, 85251, United States

Primary Outcome

  • Sum of Total Pain Relief (TOTPAR) over 0-12 hours
    Pain relief was measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values.
    date_rangeTime Frame:
    Up to 12 hours post-dose

Secondary Outcome

  • Summed Pain Intensity Difference (SPID) over 0-12 hours
    Pain intensity was measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each postdose time point, pain intensity differences (PIDs) were derived by subtracting the pain intensity at the postdose time point from the baseline intensity score (baseline score – post-baseline score). A positive difference was indicative of improvement. Time-weighted summed pain intensity differences (SPIDs) were calculated by multiplying the PID score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values.
    date_rangeTime Frame:
    Up to 12 hours post-dose
  • SPID over 0-6 hours
    Pain intensity was measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each postdose time point, pain intensity differences (PIDs) were derived by subtracting the pain intensity at the postdose time point from the baseline intensity score (baseline score – post-baseline score). A positive difference was indicative of improvement. Time-weighted summed pain intensity differences (SPIDs) were calculated by multiplying the PID score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values.
    date_rangeTime Frame:
    Up to 6 hours post-dose
  • SPID over 6-12 hours
    Pain intensity was measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each postdose time point, pain intensity differences (PIDs) were derived by subtracting the pain intensity at the postdose time point from the baseline intensity score (baseline score – post-baseline score). A positive difference was indicative of improvement. Time-weighted summed pain intensity differences (SPIDs) were calculated by multiplying the PID score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values.
    date_rangeTime Frame:
    From 6 hours to 12 hours post-dose
  • TOTPAR over 0-6 hours
    Pain relief was measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values.
    date_rangeTime Frame:
    Up to 6 hours post-dose
  • TOTPAR 6-12 hours
    Pain relief was measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values.
    date_rangeTime Frame:
    From 6 hours to 12 hours post-dose
  • Time to first intake of rescue medication
    Time to first intake of rescue medication was defined as the number of hours elapsed between time of dose and time of rescue medication in each treatment period. Participants would be censored at time of last pain assessment.
    date_rangeTime Frame:
    Up to 12 hours post-dose
  • Pain Intensity Difference (PID) scores at each evaluation
    Pain intensity was measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each postdose time point, pain intensity differences (PIDs) were derived by subtracting the pain intensity at the postdose time point from the baseline intensity score (baseline score – post-baseline score). A positive difference was indicative of improvement.
    date_rangeTime Frame:
    Up to 12 hours post-dose
  • Number of Participants by Global Evaluation Scores
    Global evaluation was performed either at 12 hours post-dose or immediately prior to the first intake of rescue medication. Global Evaluation Score was based on the question 'Overall, I would rate the effectiveness of the study medication in relieving my menstrual pain as: 0=Poor, 1=Fair, 2=Good, 3=Very Good, 4=Excellent.'
    date_rangeTime Frame:
    Up to 12 hours post-dose
  • Pain relief scores at each evaluation
    Pain relief was measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief).
    date_rangeTime Frame:
    Up to 12 hours post-dose

Trial design

A Double-Blind, Randomized, Crossover Study to Assess Menstrual Cramp Pain Associated with Primary Dysmenorrhea
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Crossover Assignment
Trial Arms
2