A Randomized, Placebo- and Active-controlled Multi-country, Multi-centre Parallel Group Study to Evaluate the Efficacy and Safety of a Fixed Dose Combination of 400 mg Ibuprofen and 100 mg Caffeine Compared to Ibuprofen 400 mg and Placebo in Patients With Acute Lower Back or Neck Pain.
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 635
- Locations
- 18
- Primary Endpoint
- Change in Pain on Movement (POM) With Regard to the Worst Procedure (WP) Between Baseline and Day 2 (Morning, 2 Hours After Drug Intake)
Study Overview
Brief Summary
To assess the efficacy and safety of a 400 mg ibuprofen/100 mg caffeine tablet in comparison to a 400 mg ibuprofen tablet for the treatment of acute lower back or neck pain. To assess the safety and tolerability of a 400 mg ibuprofen/100 mg caffeine tablet in comparison to a 400 mg ibuprofen tablet and a placebo tablet.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
ibuprofen + caffeine
Fixed Dose Combination
Intervention: caffeine (Drug)
ibuprofen
Intervention: ibuprofen (Drug)
ibuprofen + caffeine
Fixed Dose Combination
Intervention: ibuprofen (Drug)
placebo
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
Change in Pain on Movement (POM) With Regard to the Worst Procedure (WP) Between Baseline and Day 2 (Morning, 2 Hours After Drug Intake)
Time Frame: Baseline and Day 2
The change in pain on movement (POM) with regard to the worst procedure (WP), i.e. the procedure with the highest pain score at baseline (POMwp), between baseline (morning of Day 1, pre-dosing) and Day 2 (morning, 2 hour (h) after drug intake). POM was assessed by the patient at the performance of one standardized, muscle group specific movement and was measured by a numerical rating scale ranging from 0 = 'no pain'to 10 = 'worst pain possible for this condition'. The procedure resulting in highest POM at baseline (worst procedure, POMWP) was repeated for an individual patient. If 2 or more procedures gave the same highest POM, the patient was asked which of the procedures giving the highest POM scores he/she considered the most unpleasant. Change in POMwp was calculated as baseline POMwp - POMwp at Day 2 - indicating a reduction in POMwp, where the result is positive.
Secondary Outcomes
- Global Assessment of Efficacy by the Patient at the End of Treatment (Morning of Day 6)(At the end of treatment (morning of Day 6))
- The Area Under the Curve (AUC) for the Procedure With the Highest Pain Score at Baseline (POMWP) Between Baseline and Day 6 (Morning) (POM(WP)AUC(120h))(Baseline, Day 1, Day 2, Day 4 and Day 6 (morning))
- Time to First Meaningful POMwp Relief Within 2 h After the First Dose of Trial Medication(Within 2 h after the first dose of trial medication)
- The Area Under the Curve (AUC) for Pain on Movement (POM) With Regard to the Worst Procedure (POMwp) Between Baseline and Day 4 (Morning) (POMwpAUC72hour (h))(Baseline, Day 1, Day 2 and Day 4 (morning))
- Change in Pressure Algometry Between Baseline and Day 2 (Morning, 2 Hour After Drug Intake)(Baseline and Day 2 (morning, 2 h after drug intake))
- Number of Patients With a Decrease in POMwp of at Least 30% or 50% Between Baseline and Day 2 (Morning, 2 h After Drug Intake)(Baseline and Day 2 (morning, 2 h after drug intake))