NCT03003000

Ibuprofen/Caffeine Lower Back or Neck Pain Study

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 635 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Back Pain
• Neck Pain

Interventions

Type	Name	Description
DRUG	ibuprofen
DRUG	caffeine
DRUG	placebo

Timeline

• Start date: 2016-12-20
• Primary completion: 2017-09-24
• Completion: 2017-09-28
• First posted: 2016-12-26
• Last updated: 2019-06-07
• Results posted: 2019-06-07

Locations

18 sites across 2 countries: Germany, Russia