Ibuprofen/Caffeine Lower Back or Neck Pain Study

ID: NCT03003000
Status: Completed
Phase: Phase 3
Start Date: December 20, 2016
First Submitted: November 17, 2016
Last Updated: February 22, 2018
Results: N/A
Organization: Boehringer Ingelheim
Sponsors & Collaborators: Boehringer Ingelheim
Location: Germany, Russian Federation
Conditions: Back Pain, Neck Pain
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Study Description

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

Condition or disease Intervention/treatment Phase

Back Pain

Neck Pain

Drug: ibuprofen
Other Names
Drug: caffeine
Other Names
Drug: placebo
Other Names
Phase 3

Tracking Information

First Submitted DateNovember 17, 2016
Last Update Posted DateFebruary 22, 2018
Actual Start DateDecember 20, 2016
Actual Completion DateSeptember 28, 2017
Actual Primary Completion DateSeptember 24, 2017
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • 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 (Day 1 morning pre-dosing) and Day 2 morning, 2 hours after drug intake. [Time Frame: 2 days]

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Area Under the Curve (AUC) for POMWP (Pain on Movement, worst pain) between baseline and the morning of Day 6 (POMWPAUC120h). [Time Frame: Baseline and Day 6]

  • Change in Pressure Algometry (PA) between baseline and Day 2 morning, 2 hours after drug intake. [Time Frame: Baseline and Day 2]

  • 4-point verbal rating scale of efficacy by the patient at the end of treatment (0 = poor, 1 = fair, 2 = good, 3 = very good) [Time Frame: 6 days]

  • Number of patients with a decrease in POMWP (Pain on Movement, worst pain) of at least 30% between baseline and Day 2 morning, 2 hours after drug intake. [Time Frame: Baseline and Day 2]

  • Number of patients with a decrease in POMWP (Pain on Movement, worst pain) of at least 50% between baseline and Day 2 morning, 2 hours after drug intake. [Time Frame: Baseline and Day 2]

  • Time to first meaningful POMWP (Pain on Movement, worst pain) relief within 2 hours after the first dose of study medication. [Time Frame: 2 hours]

  • Area Under the Curve (AUC) for POMWP (Pain on Movement, worst pain) between baseline and the morning of Day 4 (POMWPAUC72h). [Time Frame: Baseline and Day 4]

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleIbuprofen/Caffeine Lower Back or Neck Pain Study
Official TitleA 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.
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

Study TypeInterventional
Study PhasePhase 3
Estimated Enrollment
635
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Double
Primary Purpose
Treatment
Conditions
Back Pain
Neck Pain
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: ibuprofen

Other Names
Drug: caffeine

Other Names
Drug: placebo

Other Names
Study Groups/Cohorts
ibuprofen + caffeine
Fixed Dose Combination

ibuprofen

placebo

Study Arms
Active Comparator ibuprofen
Drug : ibuprofen

Experimental ibuprofen + caffeine
Fixed Dose Combination
Drug : caffeine

Experimental ibuprofen + caffeine
Fixed Dose Combination
Drug : ibuprofen

Placebo Comparator placebo
Drug : placebo

Arm Intervention/Treatment
Active Comparator ibuprofen
Drug : ibuprofen
Experimental ibuprofen + caffeine
Fixed Dose Combination
Drug : caffeine
Experimental ibuprofen + caffeine
Fixed Dose Combination
Drug : ibuprofen
Placebo Comparator placebo
Drug : placebo

Recruitment Information

Recruitment Status:Completed
Enrollment635
Completion DateSeptember 28, 2017
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
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
Germany
Russian Federation

Administrative Information

NCT Number:NCT03003000
Other Study ID Numbers
1335.5
2016-000902-12
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Boehringer Ingelheim
Collaborators
Not Available
Investigators
Study Chair
Boehringer Ingelheim
Boehringer Ingelheim