Trial · NCT03003000
Ibuprofen/Caffeine Lower Back or Neck Pain Study
NCT03003000, Phase 3, Completed, Boehringer Ingelheim; results first posted 2019-06-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Ibuprofen/Caffeine Lower Back or Neck Pain Study. Trials, record NCT03003000. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03003000
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ibuprofen/Caffeine Lower Back or Neck Pain Study
- NCT number
- NCT03003000
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 635 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Back Pain, Neck Pain
- Interventions
- ibuprofen, caffeine, placebo
- First posted
- 2016-12-26
- Last updated
- 2019-06-07
- Other registries' IDs
- eudract:2016-000902-12
- Results first posted
- 2019-06-07
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Pain on Movement (POM) With Regard to the Worst Procedure (WP) Between Baseline and Day 2 (Morning, 2 Hours After Drug Intake) | 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. |
| Secondary | 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) | 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 |
| Secondary | 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) | 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. |
| Secondary | 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) | 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. |
| Secondary | 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) | 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). |
| Secondary | 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) | 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. |
| Secondary | Time to First Meaningful POMwp Relief Within 2 h After the First Dose of Trial Medication | 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Pain on Movement (POM) With Regard to the Worst Procedure (WP) Between Baseline and Day 2 (Morning, 2 Hours After Drug Intake) | Baseline and Day 2 | Full analysis set (FAS): FAS comprised all patients in the TS who provided a baseline value for POMWP at Visit 1 (before drug intake) and at least 1 POMWP post-treatment value at Visit 1 (Day 1 morning, 2 h after drug intake) and at Visit 2 (Day 2, morning, 2 h after drug intake). | Unit on scale | LEAST_SQUARES_MEAN |
| SECONDARY | 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) | Treated Set (TS): The TS comprised all randomised patients who took at least 1 dose of trial medication. | Unit on scale | LEAST_SQUARES_MEAN |
| SECONDARY | 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) | TS | Unit on scale | LEAST_SQUARES_MEAN |
| SECONDARY | 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) | TS | newton/centimeter² (N/cm^2) | LEAST_SQUARES_MEAN |
| SECONDARY | 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) | TS including participants with available data for global assessment of efficacy | Participants | NUMBER |
| SECONDARY | 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) | TS | Participants | NUMBER |
| SECONDARY | Time to First Meaningful POMwp Relief Within 2 h After the First Dose of Trial Medication | Within 2 h after the first dose of trial medication | TS | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Pain on Movement (POM) With Regard to the Worst Procedure (WP) Between Baseline and Day 2 (Morning, 2 Hours After Drug Intake) | Placebo | 1.712 | Standard Error 0.1422 | Unit on scale | |
| Change in Pain on Movement (POM) With Regard to the Worst Procedure (WP) Between Baseline and Day 2 (Morning, 2 Hours After Drug Intake) | Ibuprofen | 1.998 | Standard Error 0.1042 | Unit on scale | |
| Change in Pain on Movement (POM) With Regard to the Worst Procedure (WP) Between Baseline and Day 2 (Morning, 2 Hours After Drug Intake) | Ibuprofen and Caffeine | 1.869 | Standard Error 0.1030 | Unit on scale | |
| 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)) | Placebo | 4.800 | Standard Error 0.1266 | Unit on scale | |
| 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)) | Ibuprofen | 4.461 | Standard Error 0.0942 | Unit on scale | |
| 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)) | Ibuprofen and Caffeine | 4.512 | Standard Error 0.0931 | Unit on scale | |
| 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)) | Placebo | 4.175 | Standard Error 0.1334 | Unit on scale | |
| 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)) | Ibuprofen | 3.718 | Standard Error 0.0992 | Unit on scale | |
| 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)) | Ibuprofen and Caffeine | 3.776 | Standard Error 0.0981 | Unit on scale | |
| Change in Pressure Algometry Between Baseline and Day 2 (Morning, 2 Hour After Drug Intake) | Placebo | -3.734 | Standard Error 0.6107 | newton/centimeter² (N/cm^2) |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 126 | |
| Overall Study | STARTED | Ibuprofen | 253 | |
| Overall Study | STARTED | Ibuprofen and Caffeine | 256 | |
| Overall Study | COMPLETED | Placebo | 121 | |
| Overall Study | COMPLETED | Ibuprofen | 249 | |
| Overall Study | COMPLETED | Ibuprofen and Caffeine | 251 | |
| Overall Study | NOT COMPLETED | Placebo | 5 | |
| Overall Study | NOT COMPLETED | Ibuprofen | 4 | |
| Overall Study | NOT COMPLETED | Ibuprofen and Caffeine | 5 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 126 |
| Total, all-cause mortality | Ibuprofen | 0 | 253 |
| Total, all-cause mortality | Ibuprofen and Caffeine | 0 | 256 |
| Total, other adverse events | Placebo | 0 | 126 |
| Total, other adverse events | Ibuprofen | 0 | 253 |
| Total, other adverse events | Ibuprofen and Caffeine | 0 | 256 |
| Total, serious adverse events | Placebo | 0 | 126 |
| Total, serious adverse events | Ibuprofen | 0 | 253 |
| Total, serious adverse events | Ibuprofen and Caffeine | 0 | 256 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03003000
GET https://conductscience.org/api/trials/v1/NCT03003000/results?page=2