Acute PainPhase 3NCT02700815

Capsaicin + Diclofenac Gel in Acute Back Pain or Neck Pain

A Phase 3 study testing Diclofenac and Capsaicin in people with Acute Pain, run by Boehringer Ingelheim at 18 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Pain
What is being tested?: Diclofenac and Capsaicin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 746 participants
Where: 18 sitesin 2 countries
Study dates: 9 May 2016to 21 Jul 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 and local legislation
Male or female patients >=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) >= 50 mm (Visual Analogue Scale 0-100) for at least one POM procedure out of 5 standardized 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

Who cannot join

History of 3 or more episodes of back or neck pain in the last 6 months excluding the current episode
Surgery due to back or neck pain or rehabilitation due to back or neck pain in the last 12 months
Back or neck pain that is attributable to any specific identifiable cause (e.g. disc prolapse, spondylolisthesis, osteomalacia, inflammatory arthritis, metabolic, neurological diseases or tumour)
Trauma or strains of the back or neck muscles within the last 3 months
Prior use within the last 3 days before Visit 1 or concomitant use of any anti-inflammatory drugs, heparinoids, muscle relaxants or analgesics. Long-acting glucocorticoids must have been discontinued 10 days before study entry. Spinal injections should have been discontinued in due time (investigator's judgement) before patient enrolment to allow complete wash-out of the active ingredient based on investigator's judgment
Non-pharmacological treatment (physiotherapy, heat treatment (e.g. heat patch, hot water bottle), or massage, acupuncture, transcutaneous electrical nerve stimulation) or locally applied pharmacological product to the back or neck area 24 hours prior study entry and during the study period

Show all 16Show fewer

Known severe hepatocellular insufficiency, severe renal insufficiency or Gilbert's syndrome (Morbus Meulengracht)
Any other medical condition that would interfere with efficacy and safety assessments based on investigator's judgement or any on-going clinical condition that would jeopardize patient's or site personnel's safety or study compliance based on investigator judgement.
Known intolerance or hypersensitivity to the active ingredients or any excipient(s).
Patients in whom attacks of asthma, bronchospasm, rhinitis or urticaria were precipitated by the intake of Acetyl salicylic acid (ASS) or other NSAIDs
Irritated skin (based on investigator's judgement), skin wounds, eczema or open injuries at application site
Negative experience in the past with heat treatments for muscle complaints
Patient not able to understand and comply with trial requirements based on investigators judgement
Alcohol or drug abuse
Participation in a clinical trial within the previous 30 days or simultaneous participation in another clinical trial
Women who are pregnant, nursing, or who plan to become pregnant while in the trial

Trial locations and contacts

18 sites in 2 countries.

Country

City, postcode or hospital

18 sites in 2 countries

Germany14 sites

emovis GMBH, Berlin
Berlin, 10629
Synexus Clinical Research GmbH
Berlin, 12627
Synexus Clinical Research GmbH
Bochum, 44787
Sport- und Präventionsmedizinische Praxis, 50933 Köln
Cologne, 50933
Dünnwaldpraxis, Köln
Cologne, 51069
Praxis Dr. Steinebach, Essen
Essen, 45277
Praxis Dr. Schaefer, 45355 Essen
Essen, 45355
Unterfrintroper Hausarztzentrum
Essen, 45359
Synexus Clinical Research GmbH
Frankfurt, 60313
Praxis Dr. Pabst, Gilching
Gilching, 82205
Praxis Dr. Dahmen, 22415 Hamburg
Hamburg, 22415
Praxis Dr. Klein, Künzing
Künzing, 94550
Synexus Clinical Research GmbH
Leipzig, 04103
Anästhesiologie Rheinbach
Rheinbach, 53359

Other trials in Germany

Russia4 sites

University Clinic of Headache, Private Practice, Moscow
Moscow, 129090
State Budget.Hlthcare Inst.City Outpatient dept #123,Therapy
Saint Petersburg, 192289
Medical Centre "Reavita", Therapy Dept., St. Petersburg
Saint Petersburg, 194325
St.Petersburg State Budget.Hlthcare Inst.City Outpat.dep#107
Saint Petersburg, 195030

Other trials in Russia

About this study

Official title: A Randomized, Controlled Multi-centre Parallel Group Study to Assess the Efficacy and Safety of Multiple Doses of a Topically Applied Combination Containing Diclofenac 2% + Capsaicin 0.075% (2 g Formulation Per Application; 2-times Daily for 5 Days) Compared to Placebo, as Well as to Diclofenac 2% and Capsaicin 0.075% in Patients With Acute Back or Neck Pain

Conditions: Acute Pain
Being tested: Diclofenac, Capsaicin, Placebo
Medical subject headings: Acute Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DiclofenacDrug
CapsaicinDrug
PlaceboDrug

Study groups in NCT02700815
Study group	Role	What they receive
Diclofenac and capsaicin	Experimental	Fixed dose combination Receives: Drug: Diclofenac; Drug: Capsaicin
Diclofenac	Active comparator	Not described Receives: Drug: Diclofenac
Capsaicin	Active comparator	Not described Receives: Drug: Capsaicin
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 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.
Measured: Baseline and Day 2

Secondary outcomes (7)

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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline and Day 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 May 201621 Jul 2017

First posted7 Mar 2016 (estimated)
Study start9 May 2016
Primary completion13 Jul 2017
Study completion21 Jul 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Acute 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
Who is masked: Participant, Investigator
Enrolment: 746 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02700815
Sponsor's protocol ID: 1358.1
Other IDs: 2015-000404-25, 2015
Status last verified: Feb 2019
First submitted: 2 Mar 2016
Last updated: 6 May 2019
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 32221866

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Controlled Multi-centre Parallel Group Study to Assess the Efficacy and Safety of Multiple Doses of a Topically Applied Combination Containing Diclofenac 2% + Capsaicin 0.075% (2 g Formulation Per Application; 2-times Daily for 5 Days) Compared to Placebo, as Well as to Diclofenac 2% and Capsaicin 0.075% in Patients With Acute Back or Neck Pain
ClinicalTrials.gov ID: NCT02700815
Acronym / sponsor ID: 1358.1
Conditions: Acute Pain
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 746 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 9 May 2016 (actual)
Primary completion: 13 Jul 2017 (actual)
Study completion: 21 Jul 2017 (actual)
First posted: 7 Mar 2016 (estimated)
Results: Posted 6 May 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Diclofenac and capsaicin	Experimental	Drug: Diclofenac, Drug: CapsaicinFixed dose combination
Diclofenac	Active comparator	Drug: Diclofenac
Capsaicin	Active comparator	Drug: Capsaicin
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 (5 listed)

Signed and dated written informed consent at Visit 1 in accordance with Good Clinical Practice and local legislation
Male or female patients >=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) >= 50 mm (Visual Analogue Scale 0-100) for at least one POM procedure out of 5 standardized 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 (16 listed)

History of 3 or more episodes of back or neck pain in the last 6 months excluding the current episode
Surgery due to back or neck pain or rehabilitation due to back or neck pain in the last 12 months
Back or neck pain that is attributable to any specific identifiable cause (e.g. disc prolapse, spondylolisthesis, osteomalacia, inflammatory arthritis, metabolic, neurological diseases or tumour)
Trauma or strains of the back or neck muscles within the last 3 months
Prior use within the last 3 days before Visit 1 or concomitant use of any anti-inflammatory drugs, heparinoids, muscle relaxants or analgesics. Long-acting glucocorticoids must have been discontinued 10 days before study entry. Spinal injections should have been discontinued in due time (investigator's judgement) before patient enrolment to allow complete wash-out of the active ingredient based on investigator's judgment

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
Diclofenac	Drug	Diclofenac, Diclofenac and capsaicin
Capsaicin	Drug	Capsaicin, Diclofenac and capsaicin
Placebo	Drug	Placebo

Primary outcome

Change in POM Between Baseline and Day 2 Evening, 1 Hour After Drug Application
Time frame: 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.

7 secondary outcomes

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

Results and safety

Results posted to the registry on 6 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo Gel	75	74
Capsaicin (0.075%) Gel	223	216
Diclofenac (2%) Gel	223	219
Diclofenac (2%) +Capsaicin (0.075%) Gel	225	218

Primary outcome: Change in POM Between Baseline and Day 2 Evening, 1 Hour After Drug Application

Time frame: Baseline and Day 2. Least squares mean (Standard Error). Unit: Units on a scale

Measure	Placebo Gel n = 75	Capsaicin (0.075%) Gel n = 222	Diclofenac (2%) Gel n = 222	Diclofenac (2%) +Capsaicin (0.075%) Gel n = 225
Value	-2.45 (0.252)	-3.26 (0.160)	-2.33 (0.160)	-3.05 (0.159)

Placebo Gel vs Diclofenac (2%) +Capsaicin (0.075%) Gel: Mean Difference (Net): -0.60 (95% CI -1.15 to -0.06), p = 0.0303, Mixed Models Analysis
Capsaicin (0.075%) Gel vs Diclofenac (2%) +Capsaicin (0.075%) Gel: Mean Difference (Net): 0.21 (95% CI -0.18 to 0.60), p = 0.2886, Mixed Models Analysis
Diclofenac (2%) Gel vs Diclofenac (2%) +Capsaicin (0.075%) Gel: Mean Difference (Net): -0.72 (95% CI -1.10 to -0.33), p = 0.0003, Mixed Models Analysis

Population analysed: 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)

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first drug administration until 2 days after the last drug administration, i.e. up to 8 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Gel	0 of 75 (0%)	4 of 75 (5.3%)	0 of 75
Capsaicin (0.075%) Gel	0 of 223 (0%)	29 of 223 (13%)	0 of 223
Diclofenac (2%) Gel	0 of 223 (0%)	7 of 223 (3.1%)	0 of 223
Diclofenac (2%) +Capsaicin (0.075%) Gel	0 of 225 (0%)	26 of 225 (11.6%)	0 of 225

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32221866Predel 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.
Related InfoLink provided by the sponsor.

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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 Diclofenac and Capsaicin in people with Acute 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 5 inclusion and 16 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 6 May 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 6 May 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 POM Between Baseline and Day 2 Evening, 1 Hour After Drug Application (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?

On the ClinicalTrials.gov record for NCT02700815, which also lists 1 linked publication.

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 6 May 2019.