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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 746
- Locations
- 15
- Primary Endpoint
- Change in POM Between Baseline and Day 2 Evening, 1 Hour After Drug Application
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Diclofenac
Intervention: Diclofenac (Drug)
Diclofenac and capsaicin
Fixed dose combination
Intervention: Diclofenac (Drug)
Diclofenac and capsaicin
Fixed dose combination
Intervention: Capsaicin (Drug)
Capsaicin
Intervention: Capsaicin (Drug)
Placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change in POM Between Baseline and Day 2 Evening, 1 Hour After Drug Application
Time Frame: 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 Outcomes
- Number of Patients With Decrease in POMwp of at Least 50% From Baseline(Baseline and day 2)
- Change From Baseline in POMwp (cm) at Day 6 Morning(Baseline and Day 6)
- Change From Baseline in Pressure Algometry (PA) at Day 2 Evening, Before Drug Application(Baseline and Day 2)
- Change From Baseline in Pressure Algometry (PA) at Day 6 Morning(Baseline and Day 6)
- 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)
- 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)
- Number of Patients With Decrease in POMwp of at Least 30% From Baseline(Baseline and day 2)