Back PainPhase 3NCT03003000
Ibuprofen/Caffeine Lower Back or Neck Pain Study
A Phase 3 study testing ibuprofen and caffeine in people with Back Pain and Neck Pain, run by Boehringer Ingelheim at 18 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- ibuprofen and caffeine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 635 participants
- Where
- 18 sitesin 2 countries
- Study dates
- 20 Dec 2016to 28 Sep 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 12Show fewer
- 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 locations and contacts
18 sites in 2 countries.
18 sites in 2 countries
Germany15 sites
Dünnwaldpraxis, Köln
Cologne, 51069
Praxis Dr. Steinebach, Essen
Essen, 45277
Praxis Dr. Schaefer, 45355 Essen
Essen, 45355
Studienzentrum Bocholderstraße
Essen, 45355
Unterfrintroper Hausarztzentrum
Essen, 45359
Praxis Dr. Pabst, Gilching
Gilching, 82205
Praxis Kai Gastl
Gilching, 82205
medicoKIT GmbH
Goch, 47574
Clinical Research Dr. Martz
Hamburg, 22143
Praxis Dr. Dahmen, 22415 Hamburg
Hamburg, 22415
Praxis Dr. Chevts, 76199 Karlsruhe
Karlsruhe, 76199
Praxis Dr. Klein, Künzing
Künzing, 94550
Anästhesiologie Rheinbach
Rheinbach, 53359
Praxis Dr. Sauter
Wangen, 88239
Neurologie und Psychiatrie / Psychotherapie
Westerstede, 26655
Russia3 sites
State Healthcare Institution, City Out-Patient's Clinic #109
Saint Petersburg, 192283
Medical Centre "Reavita Med SPb" LLC
Saint Petersburg, 194325
City Outpatient dep.no.107;clinc.pharmacology,st.petersburg
Saint Petersburg, 195030
About this 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.
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.
- Being tested
- ibuprofen, caffeine, placebo
- Medical subject headings
- Back Pain, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ibuprofenDrug
caffeineDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| ibuprofen + caffeine | Experimental | Fixed Dose Combination Receives: Drug: ibuprofen; Drug: caffeine |
| ibuprofen | Active comparator | Not described Receives: Drug: ibuprofen |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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))
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
Measured: 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))
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.
Measured: 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)
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.
Measured: 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)
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).
Measured: 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)
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.
Measured: 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.
Measured: Within 2 h after the first dose of trial medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2016 (estimated)
- Study start20 Dec 2016
- Primary completion24 Sep 2017
- Study completion28 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Back PainStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 635 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03003000
- Sponsor's protocol ID
- 1335.5
- Other IDs
- 2016-000902-12, 2016
- Status last verified
- Mar 2019
- First submitted
- 17 Nov 2016
- Last updated
- 7 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03003000
- Acronym / sponsor ID
- 1335.5
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 635 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2016 (actual)
- Primary completion
- 24 Sep 2017 (actual)
- Study completion
- 28 Sep 2017 (actual)
- First posted
- 26 Dec 2016 (estimated)
- Results
- Posted 7 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ibuprofen + caffeine | Experimental | Drug: ibuprofen, Drug: caffeineFixed Dose Combination |
| ibuprofen | Active comparator | Drug: ibuprofen |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ibuprofen | Drug | ibuprofen, ibuprofen + caffeine |
| caffeine | Drug | ibuprofen + caffeine |
| placebo | Drug | placebo |
Primary outcome
Change in Pain on Movement (POM) With Regard to the Worst Procedure (WP) Between Baseline and Day 2 (Morning, 2 Hours After Drug Intake)
Time frame: Baseline and Day 2
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.
6 secondary outcomes
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))
Time frame: 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))
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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 frame: Within 2 h after the first dose of trial medication
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
Related trials for Back Pain
Not yet recruitingPhase 3
Veterans' Intervention Blending NeuRomodulation and YogA for Chronic Low BackPaiN Treatment: VIBRANT
Chronic Low Back Pain, Musculoskeletal Pain
Not yet recruitingPhase 2
Psilocybin-Assisted Physical Therapy in Chronic Low Back Pain
Chronic Low Back Pain (CLBP), Physical Therapy
Recruiting
Effect of Ultrasound-Guided Posterior Cutaneous Nerve of the Forearm Epicondylar Branch Block on Pain and Function in Lateral Epicondylitis (PCNF-BrEpi)
Lateral Epicondylitis
Not yet recruitingPhase 2/3
PRP Versus NP Injections for Chronic Discogenic Low Back Pain
Discogenic Low Back Pain
Not yet recruiting
Dual-Task Core Stabilization Training in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ibuprofen and caffeine in people with Back Pain and Neck Pain, run by Boehringer Ingelheim at 18 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Germany, Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain on Movement (POM) With Regard to the Worst Procedure (WP) Between Baseline and Day 2 (Morning, 2 Hours After Drug Intake) (time frame: Baseline and Day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2019.