Ibuprofen/Caffeine Lower Back or Neck Pain Study
- Registration Number
- NCT03003000
- Lead Sponsor
- Boehringer Ingelheim
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 635
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ibuprofen + caffeine caffeine Fixed Dose Combination ibuprofen ibuprofen - placebo placebo - ibuprofen + caffeine ibuprofen Fixed Dose Combination
- Primary Outcome Measures
Name Time Method Change in Pain on Movement (POM) With Regard to the Worst Procedure (WP) Between Baseline and Day 2 (Morning, 2 Hours After Drug Intake) 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 Outcome Measures
Name Time Method 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) Global assessment of efficacy by the patient at the end of treatment (morning of Day 6) is presented. The patient/investigator assessed the overall efficacy of the trial treatment on a 4-point verbal rating scale by answering the question: "How would you rate the overall effect of the trial medication for relieving back or neck pain?" (0 = poor; 1 = fair; 2 = good; 3 = very good).
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) This is a key secondary endpoint. The area under the curve for pain on movement with regard to the worst procedure between baseline and Day 6 (morning) (POM(WP)AUC(120h).
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'. A higher AUC value indicates higher POMwp.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 Time to event analysis of patients with first meaningful POMwp relief within 2 h after the first dose of trial medication. The percentage of observed patients with a meaningful POMwp relief within 2 h after the first dose of trial medication was reported. The procedure which resulted in the highest POM at baseline (POMwp) was repeated by the investigator 10, 20, 30, 60 and 120 min after the first dose of trial medication. The POMwp relief score (POMwpRS) was assessed by the patient at each of these time points by using a 5-point verbal rating scale (0 = no POMwp relief; 1 = little or perceptible POMwp relief; 2 = meaningful POMwp relief; 3 = a lot of POMwp relief; 4 = complete POMwp relief).
The time to first meaningful POMWP relief was the earliest assessment time point after the first application of the trial medication at which the patient reported a score of ≥2.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) This is a key secondary endpoint. The area under the curve (AUC) for pain on movement (POM) with regard to the worst procedure (POMwp) between baseline and Day 4 (morning), (POMwpAUC72h ). 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'. A higher AUC value indicates higher POMwp
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) Change in pressure algometry between baseline and Day 2 (morning, 2 h after drug intake).
Pressure algometry was determined by the investigator as the pressure value (N/cm2) at a defined trigger point which is located in the area of POMWP. The measurement was performed by using a Somedic Algometer (Somedic AB, Sweden) or an equivalent calibrated and certified device. The pain reaction was determined by placing the algometer on the trigger point, i.e. an area of 1 cm² for which the patient indicated most painful tenderness. The pressure was constantly increased until the patient asked not to increase the pressure anymore. Upon this pain reaction, the corresponding pressure value was documented in the Electronic case report form (eCRF). The trigger point was to be marked with a ball pen to be able to repeat the subsequent assessment at the same position. Change in pressure was calculated as baseline pressure - pressure at Day 2, with a negative result indicating an improvement.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) 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.
Trial Locations
- Locations (18)
Praxis Dr. Steinebach, Essen
🇩🇪Essen, Germany
Praxis Dr. Pabst, Gilching
🇩🇪Gilching, Germany
Praxis Dr. Klein, Künzing
🇩🇪Künzing, Germany
Medical Centre "Reavita Med SPb" LLC
🇷🇺St. Petersburg, Russian Federation
medicoKIT GmbH
🇩🇪Goch, Germany
Praxis Dr. Chevts, 76199 Karlsruhe
🇩🇪Karlsruhe, Germany
Dünnwaldpraxis, Köln
🇩🇪Köln, Germany
Praxis Kai Gastl
🇩🇪Gilching, Germany
Praxis Dr. Sauter
🇩🇪Wangen, Germany
Neurologie und Psychiatrie / Psychotherapie
🇩🇪Westerstede, Germany
Unterfrintroper Hausarztzentrum
🇩🇪Essen, Germany
Anästhesiologie Rheinbach
🇩🇪Rheinbach, Germany
Clinical Research Dr. Martz
🇩🇪Hamburg, Germany
Praxis Dr. Dahmen, 22415 Hamburg
🇩🇪Hamburg, Germany
Praxis Dr. Schaefer, 45355 Essen
🇩🇪Essen, Germany
Studienzentrum Bocholderstraße
🇩🇪Essen, Germany
City Outpatient dep.no.107;clinc.pharmacology,st.petersburg
🇷🇺St. Petersburg, Russian Federation
State Healthcare Institution, City Out-Patient's Clinic #109
🇷🇺St. Petersburg, Russian Federation