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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-000404-25 | EudraCT Number |
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This randomised, controlled multi-centre parallel group trial will assess the efficacy and tolerability of a topical formulation gel of the combination of diclofenac and capsaicin in comparison to gels with diclofenac alone, capsaicin alone, and placebo for the treatment of acute back pain or neck pain
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diclofenac and capsaicin | Experimental | Fixed dose combination |
|
| Diclofenac | Active Comparator |
| |
| Capsaicin | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diclofenac | Drug |
| ||
| Capsaicin |
| Measure | Description | Time Frame |
|---|---|---|
| Change in POM Between Baseline and Day 2 Evening, 1 Hour After Drug Application | Pain on movement (POM) was used to assess pain measurement for back and neck pain. The standardized movements have been established for which the measurement was taken. POMwp was the POM measure that gave the highest score at baseline; i.e. POM of worst procedure. Pain intensity was assessed at rest after standing in an upright position relatively motionless for 1 minute. The pain was evaluated by asking patient 'How would you rate your pain right now?' and by using a visual analogue scale (VAS) ranging from 0-10 centimeters (cm) wherein 0 cm = no pain to 10 cm = worst pain possible. The results presented here are adjusted mean change from baseline and standard error for POMwp in cm. | Baseline and Day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| POMwp Area Under the Curve (AUC) Calculated From 0 to 72 Hours (h) (POMwp AUC(0-72 h)) | This is a key secondary endpoint. AUC for POMwp calculated from 0 to 72 h that is for first three treatment days using the trapezoidal rule divided by the observation time. The results presented here are adjusted mean and standard error for POMwp AUC (0-72 h) in centimeters (cm). The AUC represents POMwp as an average over the first 3 treatment days (Day 1 until Day 4 morning) - it is not meant here as a pharmacokinetics (PK) parameter (concentration over time). |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| emovis GMBH, Berlin | Berlin | 10629 | Germany | |||
| Synexus Clinical Research GmbH |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32221866 | Derived | Predel HG, Ebel-Bitoun C, Peil B, Weiser TW, Lange R. Efficacy and Safety of Diclofenac + Capsaicin Gel in Patients with Acute Back/Neck Pain: A Multicenter Randomized Controlled Study. Pain Ther. 2020 Jun;9(1):279-296. doi: 10.1007/s40122-020-00161-9. Epub 2020 Mar 27. |
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All subjects were screened for eligibility to participate in the trial. Subjects attended specialist sites which would then ensure that all subjects met all inclusion/exclusion criteria. Subjects were not to be entered to trial if any of the specific entry criteria were not met.
This was a randomised, placebo and active treatment-controlled, double-blind, parallel group study. Out of 757 enrolled patients with acute back or neck pain, 746 were randomised and treated with 4 topical treatments administered twice daily for 4 to 7 days.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Gel | Patients were topically applied matching Placebo 2 gram (g) gel, twice daily with 12 ± 4 hours (h) between applications. |
| FG001 | Capsaicin (0.075%) Gel | Patients were topically applied Capsaicin 2 g gel (1.5 milligram (mg) Capsaicin), twice daily with 12 ± 4 hours (h) between applications. |
| FG002 | Diclofenac (2%) Gel | Patients were topically applied Diclofenac 2 g gel (40 milligram (mg) Diclofenac), twice daily with 12 ± 4 hours (h) between applications. |
| FG003 | Diclofenac (2%) +Capsaicin (0.075%) Gel | Patients were topically applied Diclofenac + Capsaicin 2 g gel (40 mg diclofenac, 1.5 mg capsaicin), twice daily with 12 ± 4 hours (h) between applications. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Treated Set (TS): All randomised patients who used at least 1 dose of study medication were included in the TS. Patients who received the wrong treatment were analysed within the planned (randomised) treatment group in the efficacy analysis and within the actual treatment group in the safety analysis (TS, as treated).
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Gel | Patients were topically applied matching Placebo 2 gram (g) gel, twice daily with 12 ± 4 hours (h) between applications. |
| BG001 | Capsaicin (0.075%) Gel | Patients were topically applied Capsaicin 2 g gel (1.5 milligram (mg) Capsaicin), twice daily with 12 ± 4 hours (h) between applications. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age of all patients included in the trial. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in POM Between Baseline and Day 2 Evening, 1 Hour After Drug Application | Pain on movement (POM) was used to assess pain measurement for back and neck pain. The standardized movements have been established for which the measurement was taken. POMwp was the POM measure that gave the highest score at baseline; i.e. POM of worst procedure. Pain intensity was assessed at rest after standing in an upright position relatively motionless for 1 minute. The pain was evaluated by asking patient 'How would you rate your pain right now?' and by using a visual analogue scale (VAS) ranging from 0-10 centimeters (cm) wherein 0 cm = no pain to 10 cm = worst pain possible. The results presented here are adjusted mean change from baseline and standard error for POMwp in cm. | Full analysis set (FAS): All patients in treated set with a baseline value pre application for POMwp at Visit 1 and at least 1 POMwp value during assessment times at Visit 1 (Day 1 morning 1h after application), Visit 2 (Day 2, morning 1h after application), Visit 3 (Day 2 evening before application) or Visit 3 (Day 2 evening 1h after application) | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline and Day 2 |
From first drug administration until 2 days after the last drug administration, i.e. up to 8 days.
An adverse event (AE) was defined as any untoward medical occurrence, including an exacerbation of a pre-existing condition, in a patient in a clinical investigation who received a pharmaceutical product. The event did not necessarily have to have a causal relationship with this treatment. TS (as treated) has been used for assessment of AEs.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Gel | Patients were topically applied matching Placebo 2 gram (g) gel, twice daily with 12 ± 4 hours (h) between applications. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Burning sensation | General disorders | 20.1 | Systematic Assessment |
A possible limitation of this study design related to the warming effect that is attributable to the topical application of capsaicin, which could potentially have led to inadvertent unblinding of treatment assignments in the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 6, 2017 | Jul 18, 2018 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jun 21, 2016 | Jul 18, 2018 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004008 | Diclofenac |
| D002211 | Capsaicin |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Drug |
|
| Placebo | Drug |
|
| 0 to 72 hours after start of treatment |
| POMwp Area Under the Curve (AUC) Calculated From 0 to 120 Hours (h) (POMwp AUC(0-120 h)) | This is a key secondary endpoint. AUC for POMwp calculated from 0 to 120 h that is for first five treatment days using the trapezoidal rule divided by the observation time. The results presented here are adjusted mean and standard error for POMwp AUC (0-120 h) in centimeters (cm). The AUC represents POMwp as an average over the first 5 treatment days (Day 1 until Day 6 morning) - it is not meant here as a PK parameter (concentration over time). | 0 to 120 hours after start of treatment |
| Number of Patients With Decrease in POMwp of at Least 30% From Baseline | This outcome measures the pattern of number of patients with a decrease in POMwp of at least 30% from baseline at 1 hour after dosing on Day 2 evening. | Baseline and day 2 |
| Number of Patients With Decrease in POMwp of at Least 50% From Baseline | This outcome measures the pattern of number of patients with a decrease in POMwp of at least 50% from baseline at 1 hour after dosing on Day 2 evening. | Baseline and day 2 |
| Change From Baseline in POMwp (cm) at Day 6 Morning | Pain on movement (POM) was used to assess pain measurement for back and neck pain. The standardized movements have been established for which the measurement was taken. POMwp was the POM measure that gave the highest score at baseline; i.e. POM of worst procedure. Pain intensity was assessed at rest after standing in an upright position relatively motionless for 1 minute. The pain was evaluated by asking patient 'How would you rate your pain right now?' and by using a visual analogue scale (VAS) ranging from 0-10 cm wherein 0 cm = no pain to 10 cm = worst pain possible. The results presented here are adjusted mean change from baseline and standard error for POMwp in centimeters (cm). | Baseline and Day 6 |
| Change From Baseline in Pressure Algometry (PA) at Day 2 Evening, Before Drug Application | PA is a method described to determine pressure pain threshold (PPT) by applying controlled pressure to a given body point. The results presented here are adjusted mean change from baseline and standard error for PA. | Baseline and Day 2 |
| Change From Baseline in Pressure Algometry (PA) at Day 6 Morning | PA is a method described to determine pressure pain threshold (PPT) by applying controlled pressure to a given body point. The results presented here are adjusted mean change from baseline and standard error for PA. | Baseline and Day 6 |
| Berlin |
| 12627 |
| Germany |
| Synexus Clinical Research GmbH | Bochum | 44787 | Germany |
| Sport- und Präventionsmedizinische Praxis, 50933 Köln | Cologne | 50933 | Germany |
| Dünnwaldpraxis, Köln | Cologne | 51069 | Germany |
| Praxis Dr. Steinebach, Essen | Essen | 45277 | Germany |
| Praxis Dr. Schaefer, 45355 Essen | Essen | 45355 | Germany |
| Unterfrintroper Hausarztzentrum | Essen | 45359 | Germany |
| Synexus Clinical Research GmbH | Frankfurt | 60313 | Germany |
| Praxis Dr. Pabst, Gilching | Gilching | 82205 | Germany |
| Praxis Dr. Dahmen, 22415 Hamburg | Hamburg | 22415 | Germany |
| Praxis Dr. Klein, Künzing | Künzing | 94550 | Germany |
| Synexus Clinical Research GmbH | Leipzig | 04103 | Germany |
| Anästhesiologie Rheinbach | Rheinbach | 53359 | Germany |
| University Clinic of Headache, Private Practice, Moscow | Moscow | 129090 | Russia |
| State Budget.Hlthcare Inst.City Outpatient dept #123,Therapy | Saint Petersburg | 192289 | Russia |
| Medical Centre "Reavita", Therapy Dept., St. Petersburg | Saint Petersburg | 194325 | Russia |
| St.Petersburg State Budget.Hlthcare Inst.City Outpat.dep#107 | Saint Petersburg | 195030 | Russia |
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Refusal to continue medication |
|
| Withdrawal by Subject |
|
| BG002 | Diclofenac (2%) Gel | Patients were topically applied Diclofenac 2 g gel (40 milligram (mg) Diclofenac), twice daily with 12 ± 4 hours (h) between applications. |
| BG003 | Diclofenac (2%) +Capsaicin (0.075%) Gel | Patients were topically applied Diclofenac + Capsaicin 2 g gel (40 mg diclofenac, 1.5 mg capsaicin), twice daily with 12 ± 4 hours (h) between applications. |
| BG004 | Total | Total of all reporting groups |
TS
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Gender distribution of all patients included in the trial. | TS | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Ethnicity of all patients included in the trial. | TS | Count of Participants | Participants |
|
| Race (NIH/OMB) | Race of all patients included in the trial. | TS | Count of Participants | Participants |
|
| Pain on movement of worst procedure (POMwp) | Pain on movement (POM) was used to assess pain measurement for back and neck pain. The standardized movements have been established for which the measurement was taken. POMwp was the POM measure that gave the highest score at baseline; i.e. POM of worst procedure. Pain intensity was assessed at rest after standing in an upright position relatively motionless for 1 minute. The pain was evaluated by asking patient 'How would you rate your pain right now?' and by using a visual analogue scale (VAS) ranging from 0-10 cm wherein 0 cm = no pain to 10 cm = worst pain possible. | TS | Mean | Standard Deviation | Units on scale |
|
| Country | The list of countries from which the respective number of patients had been enrolled. | TS | Number | Participants |
|
| Application site | POM was assessed by patients on performance of standardized, muscle group specific movements measured using a VAS on application sites. Back and Neck were defined as application sites for this study. Acute back and neck pain was studied in this trial. Number of patients with either neck or back as an application site were presented here. | TS | Number | Participants |
|
| ID | Title | Description |
|---|
| OG000 | Placebo Gel | Patients were topically applied matching Placebo 2 gram (g) gel, twice daily with 12 ± 4 hours (h) between applications. |
| OG001 | Capsaicin (0.075%) Gel | Patients were topically applied Capsaicin 2 g gel (1.5 milligram (mg) Capsaicin), twice daily with 12 ± 4 hours (h) between applications. |
| OG002 | Diclofenac (2%) Gel | Patients were topically applied Diclofenac 2 g gel (40 milligram (mg) Diclofenac), twice daily with 12 ± 4 hours (h) between applications. |
| OG003 | Diclofenac (2%) +Capsaicin (0.075%) Gel | Patients were topically applied Diclofenac + Capsaicin 2 g gel (40 mg diclofenac, 1.5 mg capsaicin), twice daily with 12 ± 4 hours (h) between applications. |
|
|
|
| Secondary | POMwp Area Under the Curve (AUC) Calculated From 0 to 72 Hours (h) (POMwp AUC(0-72 h)) | This is a key secondary endpoint. AUC for POMwp calculated from 0 to 72 h that is for first three treatment days using the trapezoidal rule divided by the observation time. The results presented here are adjusted mean and standard error for POMwp AUC (0-72 h) in centimeters (cm). The AUC represents POMwp as an average over the first 3 treatment days (Day 1 until Day 4 morning) - it is not meant here as a pharmacokinetics (PK) parameter (concentration over time). | Treated set (TS) | Posted | Least Squares Mean | Standard Error | cm | 0 to 72 hours after start of treatment |
|
|
|
|
| Secondary | POMwp Area Under the Curve (AUC) Calculated From 0 to 120 Hours (h) (POMwp AUC(0-120 h)) | This is a key secondary endpoint. AUC for POMwp calculated from 0 to 120 h that is for first five treatment days using the trapezoidal rule divided by the observation time. The results presented here are adjusted mean and standard error for POMwp AUC (0-120 h) in centimeters (cm). The AUC represents POMwp as an average over the first 5 treatment days (Day 1 until Day 6 morning) - it is not meant here as a PK parameter (concentration over time). | TS | Posted | Least Squares Mean | Standard Error | cm | 0 to 120 hours after start of treatment |
|
|
|
|
| Secondary | Number of Patients With Decrease in POMwp of at Least 30% From Baseline | This outcome measures the pattern of number of patients with a decrease in POMwp of at least 30% from baseline at 1 hour after dosing on Day 2 evening. | TS | Posted | Number | Participants | Baseline and day 2 |
|
|
|
|
| Secondary | Number of Patients With Decrease in POMwp of at Least 50% From Baseline | This outcome measures the pattern of number of patients with a decrease in POMwp of at least 50% from baseline at 1 hour after dosing on Day 2 evening. | TS | Posted | Number | Participants | Baseline and day 2 |
|
|
|
|
| Secondary | Change From Baseline in POMwp (cm) at Day 6 Morning | Pain on movement (POM) was used to assess pain measurement for back and neck pain. The standardized movements have been established for which the measurement was taken. POMwp was the POM measure that gave the highest score at baseline; i.e. POM of worst procedure. Pain intensity was assessed at rest after standing in an upright position relatively motionless for 1 minute. The pain was evaluated by asking patient 'How would you rate your pain right now?' and by using a visual analogue scale (VAS) ranging from 0-10 cm wherein 0 cm = no pain to 10 cm = worst pain possible. The results presented here are adjusted mean change from baseline and standard error for POMwp in centimeters (cm). | TS | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline and Day 6 |
|
|
|
|
| Secondary | Change From Baseline in Pressure Algometry (PA) at Day 2 Evening, Before Drug Application | PA is a method described to determine pressure pain threshold (PPT) by applying controlled pressure to a given body point. The results presented here are adjusted mean change from baseline and standard error for PA. | TS | Posted | Least Squares Mean | Standard Error | Newton/centimeter square (N/cm^2) | Baseline and Day 2 |
|
|
|
|
| Secondary | Change From Baseline in Pressure Algometry (PA) at Day 6 Morning | PA is a method described to determine pressure pain threshold (PPT) by applying controlled pressure to a given body point. The results presented here are adjusted mean change from baseline and standard error for PA. | TS | Posted | Least Squares Mean | Standard Error | Newton/centimeter square (N/cm^2) | Baseline and Day 6 |
|
|
|
|
| 0 |
| 75 |
| 0 |
| 75 |
| 4 |
| 75 |
| EG001 | Capsaicin (0.075%) Gel | Patients were topically applied Capsaicin 2 g gel (1.5 milligram (mg) Capsaicin), twice daily with 12 ± 4 hours (h) between applications. | 0 | 223 | 0 | 223 | 29 | 223 |
| EG002 | Diclofenac (2%) Gel | Patients were topically applied Diclofenac 2 g gel (40 milligram (mg) Diclofenac), twice daily with 12 ± 4 hours (h) between applications. | 0 | 223 | 0 | 223 | 7 | 223 |
| EG003 | Diclofenac (2%) +Capsaicin (0.075%) Gel | Patients were topically applied Diclofenac + Capsaicin 2 g gel (40 mg diclofenac, 1.5 mg capsaicin), twice daily with 12 ± 4 hours (h) between applications. | 0 | 225 | 0 | 225 | 26 | 225 |
| Nasopharyngitis | Infections and infestations | 20.1 | Systematic Assessment |
|
| Skin burning sensation | Skin and subcutaneous tissue disorders | 20.1 | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| D053284 |
| Polyunsaturated Alkamides |
| D000577 | Amides |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D005229 | Fatty Acids, Monounsaturated |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| An analysis of covariance (ANCOVA) was used to compare POMwp AUC(0-72 h) between capsaicin and combination therapy diclofenac + capsaicin | ANCOVA | ANCOVA includes treatment, country, and application site (back/neck) as fixed effects, and baseline POMwp as a continuous covariate. | 0.0564 | Mean Difference (Net) | 0.30 | Standard Error of the Mean | 0.157 | 2-Sided | 95 | -0.01 | 0.61 | The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences. | Superiority |
| An analysis of covariance (ANCOVA) was used to compare POMwp AUC(0-72 h) between diclofenac and combination therapy diclofenac + capsaicin | ANCOVA | ANCOVA includes treatment, country, and application site (back/neck) as fixed effects, and baseline POMwp as a continuous covariate. | 0.0004 | Mean Difference (Net) | -0.56 | Standard Error of the Mean | 0.157 | 2-Sided | 95 | -0.87 | -0.25 | The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences. | Superiority |
| An analysis of covariance (ANCOVA) was used to compare POMwp AUC(0-120 h) between capsaicin and combination therapy diclofenac + capsaicin | ANCOVA | ANCOVA includes treatment, country, and application site (back/neck) as fixed effects, and baseline POMwp as a continuous covariate. | 0.0622 | Mean Difference (Net) | 0.32 | Standard Error of the Mean | 0.169 | 2-Sided | 95 | -0.02 | 0.65 | The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences. | Superiority |
| An analysis of covariance (ANCOVA) was used to compare POMwp AUC(0-120 h) between diclofenac and combination therapy diclofenac + capsaicin | ANCOVA | ANCOVA includes treatment, country, and application site (back/neck) as fixed effects, and baseline POMwp as a continuous covariate. | <0.0001 | Mean Difference (Net) | -0.68 | Standard Error of the Mean | 0.169 | 2-Sided | 95 | -1.01 | -0.35 | The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences. | Superiority |
| A logistic regression was used to compare change in number of patients with a decrease in POMwp of at least 30% from baseline between capsaicin and combination therapy diclofenac + capsaicin. The likelihood-ratio test was used to test for differences between treatments. | Regression, Logistic | Logistic regression model include country and application site as covariates. Odds ratio was calculated as combination treatment/individual treatment. | 0.1206 | Odds Ratio (OR) | 0.732 | 2-Sided | 95 | 0.49 | 1.09 | Superiority |
| A logistic regression was used to compare change in number of patients with a decrease in POMwp of at least 30% from baseline between diclofenac and combination therapy diclofenac + capsaicin. The likelihood-ratio test was used to test for differences between treatments. | Regression, Logistic | Logistic regression model include country and application site as covariates. Odds ratio was calculated as combination treatment/individual treatment. | 0.0122 | Odds Ratio (OR) | 1.629 | 2-Sided | 95 | 1.11 | 2.39 | Superiority |
| A logistic regression was used to compare change in number of patients with a decrease in POMwp of at least 50% from baseline between capsaicin and combination therapy diclofenac + capsaicin. The likelihood-ratio test was used to test for differences between treatments. | Regression, Logistic | Logistic regression model include country and application site as covariates. Odds ratio was calculated as combination treatment/individual treatment. | 0.3479 | Odds Ratio (OR) | 0.833 | 2-Sided | 95 | 0.57 | 1.22 | Superiority |
| A logistic regression was used to compare change in number of patients with a decrease in POMwp of at least 50% from baseline between diclofenac and combination therapy diclofenac + capsaicin. The likelihood-ratio test was used to test for differences between treatments. | Regression, Logistic | Logistic regression model include country and application site as covariates. Odds ratio was calculated as combination treatment/individual treatment. | 0.0004 | Odds Ratio (OR) | 2.125 | 2-Sided | 95 | 1.40 | 3.22 | Superiority |
| A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in POMwp from baseline between capsaicin and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline POMwp and baseline POMwp by time interaction. | Mixed Models Analysis | 0.3726 | Mean Difference (Net) | 0.20 | Standard Error of the Mean | 0.223 | 2-Sided | 95 | -0.24 | 0.64 | The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences. | Superiority |
| A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in POMwp from baseline between diclofenac and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline POMwp and baseline POMwp by time interaction. | Mixed Models Analysis | <0.0001 | Mean Difference (Net) | -1.12 | Standard Error of the Mean | 0.223 | 2-Sided | 95 | -1.56 | -0.68 | The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences. | Superiority |
| A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in PA from baseline between capsaicin and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline PA and baseline PA by time interaction. | Mixed Models Analysis | 0.6094 | Mean Difference (Net) | 0.31 | Standard Error of the Mean | 0.601 | 2-Sided | 95 | -0.87 | 1.49 | The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences. | Superiority |
| A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in PA from baseline between diclofenac and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline PA and baseline PA by time interaction. | Mixed Models Analysis | 0.2047 | Mean Difference (Net) | 0.76 | Standard Error of the Mean | 0.602 | 2-Sided | 95 | -0.42 | 1.95 | The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences. | Superiority |
| A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in PA from baseline between capsaicin and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline PA and baseline PA by time interaction. | Mixed Models Analysis | 0.7672 | Mean Difference (Net) | 0.28 | Standard Error of the Mean | 0.949 | 2-Sided | 95 | -1.58 | 2.15 | The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences. | Superiority |
| A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in PA from baseline between diclofenac and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline PA and baseline PA by time interaction. | Mixed Models Analysis | 0.0339 | Mean Difference (Net) | 2.02 | Standard Error of the Mean | 0.950 | 2-Sided | 95 | 0.15 | 3.88 | The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences. | Superiority |