Ibuprofen/Caffeine Lower Back or Neck Pain Study

NCT ID: NCT03003000

Last Updated: 2019-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 635 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-20
• Study Completion Date: 2017-09-28

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.

Conditions

Back Pain; Neck Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ibuprofen + caffeine

Fixed Dose Combination

Group Type: EXPERIMENTAL

ibuprofen

Intervention Type: DRUG

caffeine

Intervention Type: DRUG

ibuprofen

Group Type: ACTIVE_COMPARATOR

ibuprofen

Intervention Type: DRUG

placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Interventions

ibuprofen

Intervention Type: DRUG

caffeine

Intervention Type: DRUG

placebo

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

Dünnwaldpraxis, Köln

Cologne, , Germany

Praxis Dr. Steinebach, Essen

Essen, , Germany

Praxis Dr. Schaefer, 45355 Essen

Essen, , Germany

Studienzentrum Bocholderstraße

Essen, , Germany

Unterfrintroper Hausarztzentrum

Essen, , Germany

Praxis Dr. Pabst, Gilching

Gilching, , Germany

Praxis Kai Gastl

Gilching, , Germany

medicoKIT GmbH

Goch, , Germany

Clinical Research Dr. Martz

Hamburg, , Germany

Praxis Dr. Dahmen, 22415 Hamburg

Hamburg, , Germany

Praxis Dr. Chevts, 76199 Karlsruhe

Karlsruhe, , Germany

Praxis Dr. Klein, Künzing

Künzing, , Germany

Anästhesiologie Rheinbach

Rheinbach, , Germany

Praxis Dr. Sauter

Wangen, , Germany

Neurologie und Psychiatrie / Psychotherapie

Westerstede, , Germany

State Healthcare Institution, City Out-Patient's Clinic #109

Saint Petersburg, , Russia

Medical Centre "Reavita Med SPb" LLC

Saint Petersburg, , Russia

City Outpatient dep.no.107;clinc.pharmacology,st.petersburg

Saint Petersburg, , Russia

Countries

Germany; Russia

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

2016-000902-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1335.5

Identifier Type: -

Identifier Source: org_study_id