Trial · NCT01708915
Nonivamide/Nicoboxil Ointment in Acute Low Back Pain
NCT01708915, Phase 3, Completed, Boehringer Ingelheim; results first posted 2014-05-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Nonivamide/Nicoboxil Ointment in Acute Low Back Pain. Trials, record NCT01708915. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01708915
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nonivamide/Nicoboxil Ointment in Acute Low Back Pain
- NCT number
- NCT01708915
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 805 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Acute Low Back Pain
- Interventions
- nicoboxil, placebo matching nonivamide + nicoboxil, nonivamide + nicoboxil (Finalgon), nonivamide
- First posted
- 2012-10-17
- Last updated
- 2014-05-29
- Other registries' IDs
- eudract:2011-003890-27
- Results first posted
- 2014-05-15
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pain Intensity Difference (PID) Between Pre-dose Baseline and 8hours After First Application | Baseline and 8 hours after first ointment application | Pain intensity (PI) was assessed on a 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst pain possible) at pre-dose baseline and 0.5, 1, 2, 3, 4, 6 and 8 hours after first ointment application. Means were adjusted for centre effect and baseline value. |
| Secondary | Pain Intensity Difference (PID) Between Pre-dose Baseline and 4 Hours After First Application | Baseline and 4 hours after first ointment application | Pain intensity was assessed on a 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst pain possible) at pre-dose baseline and 0.5, 1, 2, 3 and 4 hours after first ointment application. Means were adjusted for centre effect and baseline value. |
| Secondary | Difference Between Baseline Pain Intensity and Average Pain Intensity on the Last Individual Treatment Day | Baseline and 1 to 4 days | Average pain intensity was assessed in the evening of days 1, 2, 3 and 4 on a 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst pain possible). The last individual treatment day is the last day with diary-recorded ointment application. Means were adjusted for centre effect and baseline value. |
| Secondary | Patient Assessment of Efficacy on the Last Individual Treatment Day | 1 to 4 days | Patient assessment of efficacy was assessed on a 4-point verbal rating scale (VRS, 0 = 'poor', 1 = 'fair', 2 = 'good', 3 = 'very good' relief of the patients' low back pain) in the evening of days 1, 2, 3 and 4. The last individual treatment day is the last day with diary-recorded ointment application |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pain Intensity Difference (PID) Between Pre-dose Baseline and 8hours After First Application | Baseline and 8 hours after first ointment application | Patients from the Full Analysis Set (FAS): all randomised patients who used at least 1 dose of study medication and provided any post-treatment data for the pain intensity difference within 8 hours after first application. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Pain Intensity Difference (PID) Between Pre-dose Baseline and 4 Hours After First Application | Baseline and 4 hours after first ointment application | Patients from FAS. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Difference Between Baseline Pain Intensity and Average Pain Intensity on the Last Individual Treatment Day | Baseline and 1 to 4 days | Patients from FAS with evaluable data for the pain intensity at baseline and for the avarage pain intensity on the last individual treatment day. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Patient Assessment of Efficacy on the Last Individual Treatment Day | 1 to 4 days | Patients from FAS. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pain Intensity Difference (PID) Between Pre-dose Baseline and 8hours After First Application | Placebo | -1.049 | Standard Error 0.106 | units on a scale | |
| Pain Intensity Difference (PID) Between Pre-dose Baseline and 8hours After First Application | Nicoboxil | -1.428 | Standard Error 0.109 | units on a scale | |
| Pain Intensity Difference (PID) Between Pre-dose Baseline and 8hours After First Application | Nonivamide | -2.252 | Standard Error 0.141 | units on a scale | |
| Pain Intensity Difference (PID) Between Pre-dose Baseline and 8hours After First Application | Nicoboxil/Nonivamide | -2.410 | Standard Error 0.138 | units on a scale | |
| Pain Intensity Difference (PID) Between Pre-dose Baseline and 4 Hours After First Application | Placebo | -0.650 | Standard Error 0.077 | units on a scale | |
| Pain Intensity Difference (PID) Between Pre-dose Baseline and 4 Hours After First Application | Nicoboxil | -0.968 | Standard Error 0.091 | units on a scale | |
| Pain Intensity Difference (PID) Between Pre-dose Baseline and 4 Hours After First Application | Nonivamide | -1.641 | Standard Error 0.110 | units on a scale | |
| Pain Intensity Difference (PID) Between Pre-dose Baseline and 4 Hours After First Application | Nicoboxil/Nonivamide | -1.699 | Standard Error 0.109 | units on a scale | |
| Difference Between Baseline Pain Intensity and Average Pain Intensity on the Last Individual Treatment Day | Placebo | -1.884 | Standard Error 0.160 | units on a scale | |
| Difference Between Baseline Pain Intensity and Average Pain Intensity on the Last Individual Treatment Day | Nicoboxil | -2.371 | Standard Error 0.160 | units on a scale |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 204 | |
| Overall Study | STARTED | Nicoboxil | 201 | |
| Overall Study | STARTED | Nonivamide | 198 | |
| Overall Study | STARTED | Nicoboxil/Nonivamide | 202 | |
| Overall Study | COMPLETED | Placebo | 118 | |
| Overall Study | COMPLETED | Nicoboxil | 139 | |
| Overall Study | COMPLETED | Nonivamide | 152 | |
| Overall Study | COMPLETED | Nicoboxil/Nonivamide | 169 | |
| Overall Study | NOT COMPLETED | Placebo | 86 | |
| Overall Study | NOT COMPLETED | Nicoboxil | 62 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Back pain | Musculoskeletal and connective tissue disorders | Placebo | 0 | 204 | |
| serious | Back pain | Musculoskeletal and connective tissue disorders | Nicoboxil | 0 | 201 | |
| serious | Back pain | Musculoskeletal and connective tissue disorders | Nonivamide | 1 | 198 | |
| serious | Back pain | Musculoskeletal and connective tissue disorders | Nicoboxil/Nonivamide | 0 | 202 |
Source ClinicalTrials.gov
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Nicoboxil | ||
| Total, all-cause mortality | Nonivamide | ||
| Total, all-cause mortality | Nicoboxil/Nonivamide | ||
| Total, other adverse events | Placebo | 0 | 204 |
| Total, other adverse events | Nicoboxil | 0 | 201 |
| Total, other adverse events | Nonivamide | 0 | 198 |
| Total, other adverse events | Nicoboxil/Nonivamide | 0 | 202 |
| Total, serious adverse events | Placebo | 0 | 204 |
| Total, serious adverse events | Nicoboxil | 0 | 201 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25929250 | DERIVED |
Source PubMed
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/NCT01708915
GET https://conductscience.org/api/trials/v1/NCT01708915/results?page=2