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Capsaicin + Diclofenac Gel in Acute Back Pain or Neck Pain

Primary Purpose

Acute Pain

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Diclofenac
Capsaicin
Placebo
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • 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

Exclusion criteria:

  • 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
  • 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

Sites / Locations

  • emovis GMBH, Berlin
  • Synexus Clinical Research GmbH
  • Synexus Clinical Research GmbH
  • Praxis Dr. Steinebach, Essen
  • Praxis Dr. Schaefer, 45355 Essen
  • Unterfrintroper Hausarztzentrum
  • Synexus Clinical Research GmbH
  • Praxis Dr. Pabst, Gilching
  • Praxis Dr. Dahmen, 22415 Hamburg
  • Sport- und Präventionsmedizinische Praxis, 50933 Köln
  • Dünnwaldpraxis, Köln
  • Praxis Dr. Klein, Künzing
  • Synexus Clinical Research GmbH
  • Anästhesiologie Rheinbach
  • University Clinic of Headache, Private Practice, Moscow
  • State Budget.Hlthcare Inst.City Outpatient dept #123,Therapy
  • Medical Centre "Reavita", Therapy Dept., St. Petersburg
  • St.Petersburg State Budget.Hlthcare Inst.City Outpat.dep#107

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Diclofenac and capsaicin

Diclofenac

Capsaicin

Placebo

Arm Description

Fixed dose combination

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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).
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.
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.
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).
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.
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.

Full Information

First Posted
March 2, 2016
Last Updated
February 5, 2019
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT02700815
Brief Title
Capsaicin + Diclofenac Gel in Acute Back Pain or Neck Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
May 9, 2016 (Actual)
Primary Completion Date
July 13, 2017 (Actual)
Study Completion Date
July 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
746 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diclofenac and capsaicin
Arm Type
Experimental
Arm Description
Fixed dose combination
Arm Title
Diclofenac
Arm Type
Active Comparator
Arm Title
Capsaicin
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Diclofenac
Intervention Type
Drug
Intervention Name(s)
Capsaicin
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in POM Between Baseline and Day 2 Evening, 1 Hour After Drug Application
Description
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.
Time Frame
Baseline and Day 2
Secondary Outcome Measure Information:
Title
POMwp Area Under the Curve (AUC) Calculated From 0 to 72 Hours (h) (POMwp AUC(0-72 h))
Description
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).
Time Frame
0 to 72 hours after start of treatment
Title
POMwp Area Under the Curve (AUC) Calculated From 0 to 120 Hours (h) (POMwp AUC(0-120 h))
Description
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).
Time Frame
0 to 120 hours after start of treatment
Title
Number of Patients With Decrease in POMwp of at Least 30% From Baseline
Description
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.
Time Frame
Baseline and day 2
Title
Number of Patients With Decrease in POMwp of at Least 50% From Baseline
Description
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.
Time Frame
Baseline and day 2
Title
Change From Baseline in POMwp (cm) at Day 6 Morning
Description
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).
Time Frame
Baseline and Day 6
Title
Change From Baseline in Pressure Algometry (PA) at Day 2 Evening, Before Drug Application
Description
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.
Time Frame
Baseline and Day 2
Title
Change From Baseline in Pressure Algometry (PA) at Day 6 Morning
Description
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.
Time Frame
Baseline and Day 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: 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 Exclusion criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
emovis GMBH, Berlin
City
Berlin
ZIP/Postal Code
10629
Country
Germany
Facility Name
Synexus Clinical Research GmbH
City
Berlin
ZIP/Postal Code
12627
Country
Germany
Facility Name
Synexus Clinical Research GmbH
City
Bochum
ZIP/Postal Code
44787
Country
Germany
Facility Name
Praxis Dr. Steinebach, Essen
City
Essen
ZIP/Postal Code
45277
Country
Germany
Facility Name
Praxis Dr. Schaefer, 45355 Essen
City
Essen
ZIP/Postal Code
45355
Country
Germany
Facility Name
Unterfrintroper Hausarztzentrum
City
Essen
ZIP/Postal Code
45359
Country
Germany
Facility Name
Synexus Clinical Research GmbH
City
Frankfurt
ZIP/Postal Code
60313
Country
Germany
Facility Name
Praxis Dr. Pabst, Gilching
City
Gilching
ZIP/Postal Code
82205
Country
Germany
Facility Name
Praxis Dr. Dahmen, 22415 Hamburg
City
Hamburg
ZIP/Postal Code
22415
Country
Germany
Facility Name
Sport- und Präventionsmedizinische Praxis, 50933 Köln
City
Köln
ZIP/Postal Code
50933
Country
Germany
Facility Name
Dünnwaldpraxis, Köln
City
Köln
ZIP/Postal Code
51069
Country
Germany
Facility Name
Praxis Dr. Klein, Künzing
City
Künzing
ZIP/Postal Code
94550
Country
Germany
Facility Name
Synexus Clinical Research GmbH
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Anästhesiologie Rheinbach
City
Rheinbach
ZIP/Postal Code
53359
Country
Germany
Facility Name
University Clinic of Headache, Private Practice, Moscow
City
Moscow
ZIP/Postal Code
129090
Country
Russian Federation
Facility Name
State Budget.Hlthcare Inst.City Outpatient dept #123,Therapy
City
St. Petersburg
ZIP/Postal Code
192289
Country
Russian Federation
Facility Name
Medical Centre "Reavita", Therapy Dept., St. Petersburg
City
St. Petersburg
ZIP/Postal Code
194325
Country
Russian Federation
Facility Name
St.Petersburg State Budget.Hlthcare Inst.City Outpat.dep#107
City
St. Petersburg
ZIP/Postal Code
195030
Country
Russian Federation

12. IPD Sharing Statement

Citations:
PubMed Identifier
32221866
Citation
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.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/
Description
Related Info

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Capsaicin + Diclofenac Gel in Acute Back Pain or Neck Pain

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