Phase 3
N=635
Ibuprofen/Caffeine Lower Back or Neck Pain Study
Back Pain · Neck Pain
Bottom Line
View on ClinicalTrials.gov: NCT03003000 ↗Enrolled (actual)
635
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Change in Pain on Movement (POM) With Regard to the Worst Procedure (WP) Between Baseline and Day 2 (Morning, 2 Hours After Drug Intake) — 1.712; 1.998; 1.869 Unit on scale — p=0.3446
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ibuprofen (Drug); caffeine (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain on Movement (POM) With Regard to the Worst Procedure (WP) Between Baseline and Day 2 (Morning, 2 Hours After Drug Intake) |
1.712; 1.998; 1.869 | 0.3446 |
| SECONDARY 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)) |
4.800; 4.461; 4.512 | 0.0474 sig |
| SECONDARY 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)) |
4.175; 3.718; 3.776 | 0.0091 sig |
| SECONDARY Change in Pressure Algometry Between Baseline and Day 2 (Morning, 2 Hour After Drug Intake) |
-3.734; -3.331; -3.175 | 0.4398 |
| SECONDARY Global Assessment of Efficacy by the Patient at the End of Treatment (Morning of Day 6) |
14; 43; 41; 46; 115; 116 | 0.0045 sig |
| SECONDARY 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) |
49; 111; 101; 17; 59; 44 | 0.9022 |
| SECONDARY Time to First Meaningful POMwp Relief Within 2 h After the First Dose of Trial Medication |
1.6; 0.8; 0.8; 1.6; 2.0; 1.2 | 0.9384 |
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.
Eligibility Criteria
Inclusion criteria
- Signed and dated written informed consent at Visit 1 in accordance with Good Clinical Practice (GCP) and local legislation.
- Male or female patients who are >=18 years with current diagnosis of acute back pain or of neck pain for at least 24 hours, but less than 21 days.
- Acute back pain or acute neck pain resulting in Pain on Movement (POM) >=5 on the 0-10 Numerical Rating Scale (NRS) for at least one POM procedure out of 5 standardised procedures.
- Sensitivity to algometric pressure on the painful trigger point = 9
- Patient with chronic back or neck pain as defined as pain for 3 weeks or longer.
- Back or neck pain that is attributable to any identifiable cause (eg. disc prolapse, spondylolisthesis, osteomalacia, inflammatory arthritis, metabolic, neurological diseases or tumour)
- Any strains of the back or neck muscles documented by clinical evaluation and anamnesis that occurred 21 days to 3 months prior to the screening visit.
- Surgery due to back or neck pain or rehabilitation due to back or neck pain in the last 12 months.
- Prior use within the last 3 days before Visit 1 or concomitant use of any anti- inflammatory drugs, heparinoids, muscle relaxants or analgesics (including but not limited to short-acting glucocorticoids, non-steroidal anti-inflammatory drugs [NSAIDs], herbal preparations) for the same indication or other indications.
- Spinal injections should have been discontinued in due time (investigator's judgment) before patient enrollment to allow complete wash-out of the active ingredient based on investigator's judgment.
- Known severe hepatocellular insufficiency, severe renal insufficiency or Gilbert's syndrome (Morbus Meulengracht)
- Patients taking Central Nervous System (CNS) or other psychotropic drugs, or any nutritional supplement known to have psychotropic effects such as St. John's Wort, Chapparal, Comfrey, Germander, Gin Bu Huan, Kava, Pennyroyal Skullcap, or Valerian within two months of taking the first dose of study medication. Patients who have been on stable doses of these medications for at least two months will be allowed into the study, as long as they maintain this dose throughout the study, and their condition is judged stable by the Principal Investigator
- Any other medical condition that would interfere with efficacy and safety assessments based on investigator's judgment or any on-going clinical condition that would jeopardize patient's or site personnel's safety or study compliance based on investigator judgment
- Further exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT03003000). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.