Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Ibuprofen and Caffeine for Acute Back or Neck Pain
NCT03003000Phase 3
Key facts
- Status
- Completed
- Start
- Dec 2016
- Primary completion
- Sep 2017
- Countries
- 2
- Sponsor
- Boehringer Ingelheim
- Modality
- Small Molecules
- Drugs
- caffeine
- Conditions
- back painCervicalgia
01
Overview
Phase 3, randomised, double-blind trial of caffeine in back pain and Cervicalgia (3 arms), sponsored by Boehringer Ingelheim. Primary endpoint: Change in Pain on Movement With Regard to the Worst Procedure Between Baseline and Day 2. Started Dec 2016; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Ibuprofen + Caffeine
Fixed dose combination of 400mg Ibuprofen and 100mg Caffeine.
Ibuprofen
400mg Ibuprofen tablet.
Placebo
Placebo tablet.
03
Who it enrols
Adults with acute back or neck pain (24h to 21 days) with Pain on Movement >= 5 and BMI < 30.
04
Endpoints
Primary
Change in Pain on Movement With Regard to the Worst Procedure Between Baseline and Day 2
Secondary
Area Under the Curve for Pain on Movement Between Baseline and Day 4
Area Under the Curve for Pain on Movement Between Baseline and Day 6
Change in Pressure Algometry Between Baseline and Day 2
Global Assessment of Efficacy by the Patient at the End of Treatment
Number of Patients With a Decrease in POMwp of at Least 30% or 50%
Time to First Meaningful POMwp Relief Within 2 h After the First Dose
05
Results
Not all primary endpoints met
Beyond the preview
Go deeper on NCT03003000.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT03003000.