CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 635 enrolled
Drug / intervention
ibuprofen +2 moredrug
Likely dose
Ibuprofen 400 mg + caffeine 100 mg (fixed-dose combination)AI-extracted
Key inclusion· 5
  • ✓Age ≥18 years with acute back or neck pain onset 24 hours to <21 days
  • ✓Pain on Movement ≥5 on 0–10 NRS for at least one of 5 standardized procedures
  • ✓Sensitivity to algometric pressure on painful trigger point ≤25 N/cm²
  • ✓BMI <30 and in good general health with no contraindications to study medications
Key exclusion· 9
  • ✕≥3 episodes of back or neck pain in the last 6 months (excluding current episode)
  • ✕Chronic back or neck pain (pain lasting ≥3 weeks)
  • ✕Pain at rest ≥9 on NRS
  • ✕Back or neck pain attributable to identifiable cause (disc prolapse, spondylolisthesis, osteomalacia, inflammatory arthritis, metabolic/neurological disease, tumor)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03003000
NCT03003000Phase 3Completed
CompareCT.gov

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.

Boehringer Ingelheim·interventional·Posted Dec 26, 2016·Updated Jun 7, 2019

In Brief

A Phase 3 clinical trial evaluating ibuprofen, caffeine, and 1 other intervention for Back Pain and Neck Pain. Completed, enrolled 635 participants across 18 sites in 2 countries.

Detailed 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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBack Pain, Neck Pain
CountriesGermany, Russia
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 26, 2016
Enrollment StartDec 20, 2016
Primary CompletionSep 24, 2017
Study CompletionSep 28, 2017
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 9.5 years ago

Interventions

ibuprofendrug

caffeinedrug

placebodrug