Ibuprofen/Caffeine Lower Back or Neck Pain Study

NCT03003000 | Completed Phase 3 Results

• 2 other identifiers: 1335.52016-000902-12
• Study Type: interventional
• Target: 635
• Locations: 2 countries
• Sites: 18

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

Outcome Measures

Primary Outcomes (1)

• Change in Pain on Movement (POM) With Regard to the Worst Procedure (WP) Between Baseline and Day 2 (Morning, 2 Hours After Drug Intake)

  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.

  Baseline and Day 2

Secondary Outcomes (6)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (3)

ibuprofen + caffeine

EXPERIMENTAL

Fixed Dose Combination

Drug: ibuprofen; Drug: caffeine

ibuprofen

ACTIVE COMPARATOR

Drug: ibuprofen

placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

ibuprofen DRUG

ibuprofen; ibuprofen + caffeine

caffeine DRUG

ibuprofen + caffeine

placebo DRUG

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (18)

Dünnwaldpraxis, Köln

Cologne, 51069, Germany

Location

Praxis Dr. Steinebach, Essen

Essen, 45277, Germany

Location

Praxis Dr. Schaefer, 45355 Essen

Essen, 45355, Germany

Location

Studienzentrum Bocholderstraße

Essen, 45355, Germany

Location

Unterfrintroper Hausarztzentrum

Essen, 45359, Germany

Location

Praxis Dr. Pabst, Gilching

Gilching, 82205, Germany

Location

Praxis Kai Gastl

Gilching, 82205, Germany

Location

medicoKIT GmbH

Goch, 47574, Germany

Location

Clinical Research Dr. Martz

Hamburg, 22143, Germany

Location

Praxis Dr. Dahmen, 22415 Hamburg

Hamburg, 22415, Germany

Location

Praxis Dr. Chevts, 76199 Karlsruhe

Karlsruhe, 76199, Germany

Location

Praxis Dr. Klein, Künzing

Künzing, 94550, Germany

Location

Anästhesiologie Rheinbach

Rheinbach, 53359, Germany

Location

Praxis Dr. Sauter

Wangen, 88239, Germany

Location

Neurologie und Psychiatrie / Psychotherapie

Westerstede, 26655, Germany

Location

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

Saint Petersburg, 192283, Russia

Location

Medical Centre "Reavita Med SPb" LLC

Saint Petersburg, 194325, Russia

Location

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

Saint Petersburg, 195030, Russia

Location

MeSH Terms

Conditions

Back Pain; Neck Pain

Interventions

Ibuprofen; Caffeine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Boehringer Ingelheim, Call Centre
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2016
• First Posted: December 26, 2016
• Study Start: December 20, 2016
• Primary Completion: September 24, 2017
• Study Completion: September 28, 2017
• Last Updated: June 7, 2019
• Results First Posted: June 7, 2019

Record last verified: 2019-03

Locations

RU (3); DE (15)