Clinical trial NCT03003000: Ibuprofen/Caffeine Lower Back or Neck Pain Study
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Back Pain
Neck Pain
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2016-12-26
Enrollment: 635
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 \<= 25 N/cm².
* Women of childbearing potential must be ready and able to use highly effective methods of birth control.
* Reliable, cooperative, and of adequate intelligence to record the requested information on the analgesic questionnaires.
* Examined by the attending physician and medically cleared to participate in the study
* In good general health, with a body mass index (BMI) \< 30, and have no contraindications to any of the study medication

Exclusion criteria:

* History of 3 or more episodes of back or neck pain in the last 6 months excluding the current episode.
* Patients with pain at rest \>= 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

Primary outcomes:
measure: Change in Pain on Movement (POM) With Regard to the Worst Procedure (WP) Between Baseline and Day 2 (Morning, 2 Hours After Drug Intake)
timeFrame: Baseline and Day 2
Secondary outcomes:
measure: 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))
timeFrame: Baseline, Day 1, Day 2 and Day 4 (morning)
measure: 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))
timeFrame: Baseline, Day 1, Day 2, Day 4 and Day 6 (morning)
measure: Change in Pressure Algometry Between Baseline and Day 2 (Morning, 2 Hour After Drug Intake)
timeFrame: Baseline and Day 2 (morning, 2 h after drug intake)
measure: Global Assessment of Efficacy by the Patient at the End of Treatment (Morning of Day 6)
timeFrame: At the end of treatment (morning of Day 6)
measure: 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)
timeFrame: Baseline and Day 2 (morning, 2 h after drug intake)
measure: Time to First Meaningful POMwp Relief Within 2 h After the First Dose of Trial Medication
timeFrame: Within 2 h after the first dose of trial medication
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Praxis Dr. Steinebach, Essen
city: Essen
country: Germany
facility: Praxis Dr. Schaefer, 45355 Essen
city: Essen
country: Germany
facility: Studienzentrum Bocholderstraße
city: Essen
country: Germany
facility: Unterfrintroper Hausarztzentrum
city: Gilching
country: Germany
facility: Praxis Dr. Pabst, Gilching
city: Gilching
country: Germany
facility: Praxis Kai Gastl
city: Goch
country: Germany
facility: medicoKIT GmbH
city: Hamburg
country: Germany
facility: Clinical Research Dr. Martz
city: Hamburg
country: Germany
facility: Praxis Dr. Dahmen, 22415 Hamburg
city: Karlsruhe
country: Germany
facility: Praxis Dr. Chevts, 76199 Karlsruhe
city: Köln
country: Germany
facility: Dünnwaldpraxis, Köln
city: Künzing
country: Germany
facility: Praxis Dr. Klein, Künzing
city: Rheinbach
country: Germany
facility: Anästhesiologie Rheinbach
city: Wangen
country: Germany
facility: Praxis Dr. Sauter
city: Westerstede
country: Germany
facility: Neurologie und Psychiatrie / Psychotherapie
city: St. Petersburg
country: Russian Federation
facility: State Healthcare Institution, City Out-Patient's Clinic #109
city: St. Petersburg
country: Russian Federation
facility: Medical Centre "Reavita Med SPb" LLC
city: St. Petersburg
country: Russian Federation
facility: City Outpatient dep.no.107;clinc.pharmacology,st.petersburg
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: