Capsaicin + Diclofenac Gel in Acute Back Pain or Neck Pain

Acute Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02700815
• Other study ID #: 1358.1
• Secondary ID: 2015-000404-25
• Status: Completed
• Phase: Phase 3
• Start date: May 9, 2016
• Est. completion date: July 21, 2017

Study information

• Verified date: February 2019
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 746
• Est. completion date: July 21, 2017
• Est. primary completion date: July 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Neck Pain

Intervention

Drug:
• Diclofenac

• Capsaicin

• Placebo

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Germany,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline and Day 2
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).	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).	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.	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.	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).	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.	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.	Baseline and Day 6

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