Back to resultsIbuprofen/Caffeine Lower Back or Neck Pain Study
Primary Purpose
Back Pain, Neck Pain
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ibuprofen
caffeine
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Back Pain
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
Sites / Locations
- Praxis Dr. Steinebach, Essen
- Praxis Dr. Schaefer, 45355 Essen
- Studienzentrum Bocholderstraße
- Unterfrintroper Hausarztzentrum
- Praxis Dr. Pabst, Gilching
- Praxis Kai Gastl
- medicoKIT GmbH
- Clinical Research Dr. Martz
- Praxis Dr. Dahmen, 22415 Hamburg
- Praxis Dr. Chevts, 76199 Karlsruhe
- Dünnwaldpraxis, Köln
- Praxis Dr. Klein, Künzing
- Anästhesiologie Rheinbach
- Praxis Dr. Sauter
- Neurologie und Psychiatrie / Psychotherapie
- State Healthcare Institution, City Out-Patient's Clinic #109
- Medical Centre "Reavita Med SPb" LLC
- City Outpatient dep.no.107;clinc.pharmacology,st.petersburg
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
ibuprofen + caffeine
ibuprofen
placebo
Arm Description
Fixed Dose Combination
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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))
This is a key secondary endpoint. The area under the curve (AUC) for pain on movement (POM) with regard to the worst procedure (POMwp) between baseline and Day 4 (morning), (POMwpAUC72h ). 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'. A higher AUC value indicates higher POMwp
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))
This is a key secondary endpoint. The area under the curve for pain on movement with regard to the worst procedure between baseline and Day 6 (morning) (POM(WP)AUC(120h).
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'. A higher AUC value indicates higher POMwp.
Change in Pressure Algometry Between Baseline and Day 2 (Morning, 2 Hour After Drug Intake)
Change in pressure algometry between baseline and Day 2 (morning, 2 h after drug intake).
Pressure algometry was determined by the investigator as the pressure value (N/cm2) at a defined trigger point which is located in the area of POMWP. The measurement was performed by using a Somedic Algometer (Somedic AB, Sweden) or an equivalent calibrated and certified device. The pain reaction was determined by placing the algometer on the trigger point, i.e. an area of 1 cm² for which the patient indicated most painful tenderness. The pressure was constantly increased until the patient asked not to increase the pressure anymore. Upon this pain reaction, the corresponding pressure value was documented in the Electronic case report form (eCRF). The trigger point was to be marked with a ball pen to be able to repeat the subsequent assessment at the same position. Change in pressure was calculated as baseline pressure - pressure at Day 2, with a negative result indicating an improvement.
Global Assessment of Efficacy by the Patient at the End of Treatment (Morning of Day 6)
Global assessment of efficacy by the patient at the end of treatment (morning of Day 6) is presented. The patient/investigator assessed the overall efficacy of the trial treatment on a 4-point verbal rating scale by answering the question: "How would you rate the overall effect of the trial medication for relieving back or neck pain?" (0 = poor; 1 = fair; 2 = good; 3 = very good).
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)
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.
Time to First Meaningful POMwp Relief Within 2 h After the First Dose of Trial Medication
Time to event analysis of patients with first meaningful POMwp relief within 2 h after the first dose of trial medication. The percentage of observed patients with a meaningful POMwp relief within 2 h after the first dose of trial medication was reported. The procedure which resulted in the highest POM at baseline (POMwp) was repeated by the investigator 10, 20, 30, 60 and 120 min after the first dose of trial medication. The POMwp relief score (POMwpRS) was assessed by the patient at each of these time points by using a 5-point verbal rating scale (0 = no POMwp relief; 1 = little or perceptible POMwp relief; 2 = meaningful POMwp relief; 3 = a lot of POMwp relief; 4 = complete POMwp relief).
The time to first meaningful POMWP relief was the earliest assessment time point after the first application of the trial medication at which the patient reported a score of ≥2.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03003000
Brief Title
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
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
December 20, 2016 (Actual)
Primary Completion Date
September 24, 2017 (Actual)
Study Completion Date
September 28, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain, Neck Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
635 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ibuprofen + caffeine
Arm Type
Experimental
Arm Description
Fixed Dose Combination
Arm Title
ibuprofen
Arm Type
Active Comparator
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ibuprofen
Intervention Type
Drug
Intervention Name(s)
caffeine
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Change in Pain on Movement (POM) With Regard to the Worst Procedure (WP) Between Baseline and Day 2 (Morning, 2 Hours After Drug Intake)
Description
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.
Time Frame
Baseline and Day 2
Secondary Outcome Measure Information:
Title
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))
Description
This is a key secondary endpoint. The area under the curve (AUC) for pain on movement (POM) with regard to the worst procedure (POMwp) between baseline and Day 4 (morning), (POMwpAUC72h ). 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'. A higher AUC value indicates higher POMwp
Time Frame
Baseline, Day 1, Day 2 and Day 4 (morning)
Title
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))
Description
This is a key secondary endpoint. The area under the curve for pain on movement with regard to the worst procedure between baseline and Day 6 (morning) (POM(WP)AUC(120h).
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'. A higher AUC value indicates higher POMwp.
Time Frame
Baseline, Day 1, Day 2, Day 4 and Day 6 (morning)
Title
Change in Pressure Algometry Between Baseline and Day 2 (Morning, 2 Hour After Drug Intake)
Description
Change in pressure algometry between baseline and Day 2 (morning, 2 h after drug intake).
Pressure algometry was determined by the investigator as the pressure value (N/cm2) at a defined trigger point which is located in the area of POMWP. The measurement was performed by using a Somedic Algometer (Somedic AB, Sweden) or an equivalent calibrated and certified device. The pain reaction was determined by placing the algometer on the trigger point, i.e. an area of 1 cm² for which the patient indicated most painful tenderness. The pressure was constantly increased until the patient asked not to increase the pressure anymore. Upon this pain reaction, the corresponding pressure value was documented in the Electronic case report form (eCRF). The trigger point was to be marked with a ball pen to be able to repeat the subsequent assessment at the same position. Change in pressure was calculated as baseline pressure - pressure at Day 2, with a negative result indicating an improvement.
Time Frame
Baseline and Day 2 (morning, 2 h after drug intake)
Title
Global Assessment of Efficacy by the Patient at the End of Treatment (Morning of Day 6)
Description
Global assessment of efficacy by the patient at the end of treatment (morning of Day 6) is presented. The patient/investigator assessed the overall efficacy of the trial treatment on a 4-point verbal rating scale by answering the question: "How would you rate the overall effect of the trial medication for relieving back or neck pain?" (0 = poor; 1 = fair; 2 = good; 3 = very good).
Time Frame
At the end of treatment (morning of Day 6)
Title
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)
Description
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.
Time Frame
Baseline and Day 2 (morning, 2 h after drug intake)
Title
Time to First Meaningful POMwp Relief Within 2 h After the First Dose of Trial Medication
Description
Time to event analysis of patients with first meaningful POMwp relief within 2 h after the first dose of trial medication. The percentage of observed patients with a meaningful POMwp relief within 2 h after the first dose of trial medication was reported. The procedure which resulted in the highest POM at baseline (POMwp) was repeated by the investigator 10, 20, 30, 60 and 120 min after the first dose of trial medication. The POMwp relief score (POMwpRS) was assessed by the patient at each of these time points by using a 5-point verbal rating scale (0 = no POMwp relief; 1 = little or perceptible POMwp relief; 2 = meaningful POMwp relief; 3 = a lot of POMwp relief; 4 = complete POMwp relief).
The time to first meaningful POMWP relief was the earliest assessment time point after the first application of the trial medication at which the patient reported a score of ≥2.
Time Frame
Within 2 h after the first dose of trial medication
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
Praxis Dr. Steinebach, Essen
City
Essen
ZIP/Postal Code
45277
Country
Germany
Facility Name
Praxis Dr. Schaefer, 45355 Essen
City
Essen
ZIP/Postal Code
45355
Country
Germany
Facility Name
Studienzentrum Bocholderstraße
City
Essen
ZIP/Postal Code
45355
Country
Germany
Facility Name
Unterfrintroper Hausarztzentrum
City
Essen
ZIP/Postal Code
45359
Country
Germany
Facility Name
Praxis Dr. Pabst, Gilching
City
Gilching
ZIP/Postal Code
82205
Country
Germany
Facility Name
Praxis Kai Gastl
City
Gilching
ZIP/Postal Code
82205
Country
Germany
Facility Name
medicoKIT GmbH
City
Goch
ZIP/Postal Code
47574
Country
Germany
Facility Name
Clinical Research Dr. Martz
City
Hamburg
ZIP/Postal Code
22143
Country
Germany
Facility Name
Praxis Dr. Dahmen, 22415 Hamburg
City
Hamburg
ZIP/Postal Code
22415
Country
Germany
Facility Name
Praxis Dr. Chevts, 76199 Karlsruhe
City
Karlsruhe
ZIP/Postal Code
76199
Country
Germany
Facility Name
Dünnwaldpraxis, Köln
City
Köln
ZIP/Postal Code
51069
Country
Germany
Facility Name
Praxis Dr. Klein, Künzing
City
Künzing
ZIP/Postal Code
94550
Country
Germany
Facility Name
Anästhesiologie Rheinbach
City
Rheinbach
ZIP/Postal Code
53359
Country
Germany
Facility Name
Praxis Dr. Sauter
City
Wangen
ZIP/Postal Code
88239
Country
Germany
Facility Name
Neurologie und Psychiatrie / Psychotherapie
City
Westerstede
ZIP/Postal Code
26655
Country
Germany
Facility Name
State Healthcare Institution, City Out-Patient's Clinic #109
City
St. Petersburg
ZIP/Postal Code
192283
Country
Russian Federation
Facility Name
Medical Centre "Reavita Med SPb" LLC
City
St. Petersburg
ZIP/Postal Code
194325
Country
Russian Federation
Facility Name
City Outpatient dep.no.107;clinc.pharmacology,st.petersburg
City
St. Petersburg
ZIP/Postal Code
195030
Country
Russian Federation
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com/
Description
Related Info
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Ibuprofen/Caffeine Lower Back or Neck Pain Study
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