Trial · NCT02700815

Capsaicin + Diclofenac Gel in Acute Back Pain or Neck Pain

NCT02700815, Phase 3, Completed, Boehringer Ingelheim; results first posted 2019-05-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Capsaicin + Diclofenac Gel in Acute Back Pain or Neck Pain. Trials, record NCT02700815. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02700815

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Capsaicin + Diclofenac Gel in Acute Back Pain or Neck Pain
NCT number: NCT02700815
Status: Completed
Phases: Phase 3
Enrollment: 746 participants, actual
Lead sponsor: Boehringer Ingelheim
Conditions: Acute Pain
Interventions: Diclofenac, Capsaicin, Placebo
First posted: 2016-03-07
Last updated: 2019-05-06
Other registries' IDs: eudract:2015-000404-25
Results first posted: 2019-05-06
Limitations and caveats: 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.

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in POM Between Baseline and Day 2 Evening, 1 Hour After Drug Application	Baseline and Day 2	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.
Secondary	POMwp Area Under the Curve (AUC) Calculated From 0 to 72 Hours (h) (POMwp AUC(0-72 h))	0 to 72 hours after start of treatment	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).
Secondary	POMwp Area Under the Curve (AUC) Calculated From 0 to 120 Hours (h) (POMwp AUC(0-120 h))	0 to 120 hours after start of treatment	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).
Secondary	Number of Patients With Decrease in POMwp of at Least 30% From Baseline	Baseline and day 2	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.
Secondary	Number of Patients With Decrease in POMwp of at Least 50% From Baseline	Baseline and day 2	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.
Secondary	Change From Baseline in POMwp (cm) at Day 6 Morning	Baseline and Day 6	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).
Secondary	Change From Baseline in Pressure Algometry (PA) at Day 2 Evening, Before Drug Application	Baseline and Day 2	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.
Secondary	Change From Baseline in Pressure Algometry (PA) at Day 6 Morning	Baseline and Day 6	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.

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in POM Between Baseline and Day 2 Evening, 1 Hour After Drug Application	Baseline and Day 2	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)	Units on a scale	LEAST_SQUARES_MEAN
SECONDARY	POMwp Area Under the Curve (AUC) Calculated From 0 to 72 Hours (h) (POMwp AUC(0-72 h))	0 to 72 hours after start of treatment	Treated set (TS)	cm	LEAST_SQUARES_MEAN
SECONDARY	POMwp Area Under the Curve (AUC) Calculated From 0 to 120 Hours (h) (POMwp AUC(0-120 h))	0 to 120 hours after start of treatment	TS	cm	LEAST_SQUARES_MEAN
SECONDARY	Number of Patients With Decrease in POMwp of at Least 30% From Baseline	Baseline and day 2	TS	Participants	NUMBER
SECONDARY	Number of Patients With Decrease in POMwp of at Least 50% From Baseline	Baseline and day 2	TS	Participants	NUMBER
SECONDARY	Change From Baseline in POMwp (cm) at Day 6 Morning	Baseline and Day 6	TS	Units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Pressure Algometry (PA) at Day 2 Evening, Before Drug Application	Baseline and Day 2	TS	Newton/centimeter square (N/cm^2)	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Pressure Algometry (PA) at Day 6 Morning	Baseline and Day 6	TS	Newton/centimeter square (N/cm^2)	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group32

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in POM Between Baseline and Day 2 Evening, 1 Hour After Drug Application	Placebo Gel	-2.45	Standard Error 0.252	Units on a scale
Change in POM Between Baseline and Day 2 Evening, 1 Hour After Drug Application	Capsaicin (0.075%) Gel	-3.26	Standard Error 0.160	Units on a scale
Change in POM Between Baseline and Day 2 Evening, 1 Hour After Drug Application	Diclofenac (2%) Gel	-2.33	Standard Error 0.160	Units on a scale
Change in POM Between Baseline and Day 2 Evening, 1 Hour After Drug Application	Diclofenac (2%) +Capsaicin (0.075%) Gel	-3.05	Standard Error 0.159	Units on a scale
POMwp Area Under the Curve (AUC) Calculated From 0 to 72 Hours (h) (POMwp AUC(0-72 h))	Placebo Gel	4.62	Standard Error 0.213	cm
POMwp Area Under the Curve (AUC) Calculated From 0 to 72 Hours (h) (POMwp AUC(0-72 h))	Capsaicin (0.075%) Gel	3.95	Standard Error 0.145	cm
POMwp Area Under the Curve (AUC) Calculated From 0 to 72 Hours (h) (POMwp AUC(0-72 h))	Diclofenac (2%) Gel	4.81	Standard Error 0.145	cm
POMwp Area Under the Curve (AUC) Calculated From 0 to 72 Hours (h) (POMwp AUC(0-72 h))	Diclofenac (2%) +Capsaicin (0.075%) Gel	4.25	Standard Error 0.143	cm
POMwp Area Under the Curve (AUC) Calculated From 0 to 120 Hours (h) (POMwp AUC(0-120 h))	Placebo Gel	3.92	Standard Error 0.230	cm
POMwp Area Under the Curve (AUC) Calculated From 0 to 120 Hours (h) (POMwp AUC(0-120 h))	Capsaicin (0.075%) Gel	3.10	Standard Error 0.156	cm

1 to 10 of 32Source ClinicalTrials.gov

See all 32 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo Gel	75
Overall Study	STARTED	Capsaicin (0.075%) Gel	223
Overall Study	STARTED	Diclofenac (2%) Gel	223
Overall Study	STARTED	Diclofenac (2%) +Capsaicin (0.075%) Gel	225
Overall Study	COMPLETED	Placebo Gel	74
Overall Study	COMPLETED	Capsaicin (0.075%) Gel	216
Overall Study	COMPLETED	Diclofenac (2%) Gel	219
Overall Study	COMPLETED	Diclofenac (2%) +Capsaicin (0.075%) Gel	218
Overall Study	NOT COMPLETED	Placebo Gel	1
Overall Study	NOT COMPLETED	Capsaicin (0.075%) Gel	7

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events12

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
other	Burning sensation	General disorders	Placebo Gel	0	75
other	Burning sensation	General disorders	Capsaicin (0.075%) Gel	16	223
other	Burning sensation	General disorders	Diclofenac (2%) Gel	1	223
other	Burning sensation	General disorders	Diclofenac (2%) +Capsaicin (0.075%) Gel	12	225
other	Nasopharyngitis	Infections and infestations	Placebo Gel	4	75
other	Nasopharyngitis	Infections and infestations	Capsaicin (0.075%) Gel	9	223
other	Nasopharyngitis	Infections and infestations	Diclofenac (2%) Gel	4	223
other	Nasopharyngitis	Infections and infestations	Diclofenac (2%) +Capsaicin (0.075%) Gel	3	225
other	Skin burning sensation	Skin and subcutaneous tissue disorders	Placebo Gel	0	75
other	Skin burning sensation	Skin and subcutaneous tissue disorders	Capsaicin (0.075%) Gel	7	223

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo Gel	0	75
Total, all-cause mortality	Capsaicin (0.075%) Gel	0	223
Total, all-cause mortality	Diclofenac (2%) Gel	0	223
Total, all-cause mortality	Diclofenac (2%) +Capsaicin (0.075%) Gel	0	225
Total, other adverse events	Placebo Gel	4	75
Total, other adverse events	Capsaicin (0.075%) Gel	29	223
Total, other adverse events	Diclofenac (2%) Gel	7	223
Total, other adverse events	Diclofenac (2%) +Capsaicin (0.075%) Gel	26	225
Total, serious adverse events	Placebo Gel	0	75
Total, serious adverse events	Capsaicin (0.075%) Gel	0	223

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
32221866	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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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