Capsaicin + Diclofenac Gel in Acute Back Pain or Neck Pain
- Registration Number
- NCT02700815
- Lead Sponsor
- Boehringer Ingelheim
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 746
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Diclofenac and capsaicin Diclofenac Fixed dose combination Diclofenac and capsaicin Capsaicin Fixed dose combination Diclofenac Diclofenac - Capsaicin Capsaicin -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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).
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.
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.
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).
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).
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.
Trial Locations
- Locations (15)
Anästhesiologie Rheinbach
🇩🇪Rheinbach, Germany
Praxis Dr. Schaefer, 45355 Essen
🇩🇪Essen, Germany
Dünnwaldpraxis, Köln
🇩🇪Köln, Germany
St.Petersburg State Budget.Hlthcare Inst.City Outpat.dep#107
🇷🇺St. Petersburg, Russian Federation
Praxis Dr. Klein, Künzing
🇩🇪Künzing, Germany
State Budget.Hlthcare Inst.City Outpatient dept #123,Therapy
🇷🇺St. Petersburg, Russian Federation
Sport- und Präventionsmedizinische Praxis, 50933 Köln
🇩🇪Köln, Germany
Unterfrintroper Hausarztzentrum
🇩🇪Essen, Germany
emovis GMBH, Berlin
🇩🇪Berlin, Germany
Synexus Clinical Research GmbH
🇩🇪Leipzig, Germany
Praxis Dr. Dahmen, 22415 Hamburg
🇩🇪Hamburg, Germany
Praxis Dr. Pabst, Gilching
🇩🇪Gilching, Germany
Praxis Dr. Steinebach, Essen
🇩🇪Essen, Germany
University Clinic of Headache, Private Practice, Moscow
🇷🇺Moscow, Russian Federation
Medical Centre "Reavita", Therapy Dept., St. Petersburg
🇷🇺St. Petersburg, Russian Federation