Clinical trial NCT02700815: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Pain
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2016-03-07
Enrollment: 746
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Change in POM Between Baseline and Day 2 Evening, 1 Hour After Drug Application
timeFrame: Baseline and Day 2
Secondary outcomes:
measure: POMwp Area Under the Curve (AUC) Calculated From 0 to 72 Hours (h) (POMwp AUC(0-72 h))
timeFrame: 0 to 72 hours after start of treatment
measure: POMwp Area Under the Curve (AUC) Calculated From 0 to 120 Hours (h) (POMwp AUC(0-120 h))
timeFrame: 0 to 120 hours after start of treatment
measure: Number of Patients With Decrease in POMwp of at Least 30% From Baseline
timeFrame: Baseline and day 2
measure: Number of Patients With Decrease in POMwp of at Least 50% From Baseline
timeFrame: Baseline and day 2
measure: Change From Baseline in POMwp (cm) at Day 6 Morning
timeFrame: Baseline and Day 6
measure: Change From Baseline in Pressure Algometry (PA) at Day 2 Evening, Before Drug Application
timeFrame: Baseline and Day 2
measure: Change From Baseline in Pressure Algometry (PA) at Day 6 Morning
timeFrame: Baseline and Day 6
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: emovis GMBH, Berlin
city: Berlin
country: Germany
facility: Synexus Clinical Research GmbH
city: Bochum
country: Germany
facility: Synexus Clinical Research GmbH
city: Essen
country: Germany
facility: Praxis Dr. Steinebach, Essen
city: Essen
country: Germany
facility: Praxis Dr. Schaefer, 45355 Essen
city: Essen
country: Germany
facility: Unterfrintroper Hausarztzentrum
city: Frankfurt
country: Germany
facility: Synexus Clinical Research GmbH
city: Gilching
country: Germany
facility: Praxis Dr. Pabst, Gilching
city: Hamburg
country: Germany
facility: Praxis Dr. Dahmen, 22415 Hamburg
city: Köln
country: Germany
facility: Sport- und Präventionsmedizinische Praxis, 50933 Köln
city: Köln
country: Germany
facility: Dünnwaldpraxis, Köln
city: Künzing
country: Germany
facility: Praxis Dr. Klein, Künzing
city: Leipzig
country: Germany
facility: Synexus Clinical Research GmbH
city: Rheinbach
country: Germany
facility: Anästhesiologie Rheinbach
city: Moscow
country: Russian Federation
facility: University Clinic of Headache, Private Practice, Moscow
city: St. Petersburg
country: Russian Federation
facility: State Budget.Hlthcare Inst.City Outpatient dept #123,Therapy
city: St. Petersburg
country: Russian Federation
facility: Medical Centre "Reavita", Therapy Dept., St. Petersburg
city: St. Petersburg
country: Russian Federation
facility: St.Petersburg State Budget.Hlthcare Inst.City Outpat.dep#107
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
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.