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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
746
emovis GMBH, Berlin
Berlin, Germany
Synexus Clinical Research GmbH
Berlin, Germany
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.
Time frame: Baseline and Day 2
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).
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))
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
Number of Patients With Decrease in POMwp of at Least 30% From Baseline
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Synexus Clinical Research GmbH
Bochum, Germany
Sport- und Präventionsmedizinische Praxis, 50933 Köln
Cologne, Germany
Dünnwaldpraxis, Köln
Cologne, Germany
Praxis Dr. Steinebach, Essen
Essen, Germany
Praxis Dr. Schaefer, 45355 Essen
Essen, Germany
Unterfrintroper Hausarztzentrum
Essen, Germany
Synexus Clinical Research GmbH
Frankfurt, Germany
Praxis Dr. Pabst, Gilching
Gilching, Germany
...and 8 more locations
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
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Baseline and Day 6