Ibuprofen/Caffeine Lower Back or Neck Pain Study

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Back Pain; Neck Pain

Treatments: Drug: placebo; Drug: caffeine; Drug: ibuprofen

Study type: Interventional

Funder types: Industry

Identifiers

NCT03003000

2016-000902-12 (EudraCT Number)

1335.5

Details and patient eligibility

About

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.

Enrollment: 635 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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635 participants in 3 patient groups, including a placebo group

ibuprofen + caffeine

Experimental group

Description:

Fixed Dose Combination

Treatment:

Drug: ibuprofen

Drug: caffeine

ibuprofen

Active Comparator group

Treatment:

Drug: ibuprofen

placebo

Placebo Comparator group

Treatment:

Drug: placebo