Pain of strains, sprains and sports injuries MedDRA version: 18.1 Level: PT Classification code 10065016 Term: Post-traumatic pain System Organ Class: 10022117 - Injury, poisoning and procedural complications
Conditions
Interventions
Trade Name: Deep Relief Pain Relief Gel
Product Name: Deep Relief
Pharmaceutical Form: Gel
INN or Proposed INN: Ibuprofen
CAS Number: 15
Sponsors
The Mentholatum Company Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Only patients to whom all of the following conditions apply will be included: 1) Patients who have given written informed consent. 2) Age: =16 to =75. 3) Both male and female patients may be included. 4) Primary diagnosis: Patients with an acute soft tissue injury. Patients who have at least moderate pain - = 6 on the pain numerical rating scale (NRS) at baseline. Are the trial subjects under 18? yes Number of subjects for this age range: 20 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 140 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Patients to whom any of the following conditions apply must be excluded: 1) Inflammed or broken skin in area of application 2) Those patients known to be hypersensitive to ibuprofen, levomenthol, or any of the ingredients or sensitive to aspirin, or other NSAIDS including when taken by mouth, or asthmatic patients in whom aspirin or non-steroidal antiinflammatories are known to precipitate asthmatic attacks, rhinitis or urticaria.. 3) Any injury considered to be chronic in the view of the Investigator. 4) active peptic ulcer 5) known significant renal disease 6) pregnant or lactating women 7) Those who have used any analgesic, within the previous 8 hours. 8) Those who have used a longer acting or slow release analgesic during the previous 24 hours e.g. Piroxicam and Naproxen. 9) Those with a history of severe hepatic impairment 10) Those with a history (within 2 years) of alcohol abuse..). 11) Those unable to refrain from smoking during their stay in the investigative site. 12) Women of childbearing potential, who report they are pregnant or lactating, seeking pregnancy or failing to take adequate contraceptive precautions, 13) Those previously randomised into the study. 14) Those who have participated in a clinical trial in the previous 30 days. Thirty days are calculated from time of last dosing in the prior trial to time of anticipated dosing in this trial. 15) Those unable in the opinion of the investigator to comply fully with the study requirements, e.g. such as those who cannot comprehend or correctly use the pain rating scales.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to determine the time to onset of significant pain relief in patients with soft tissue injuries of ibuprofen gel, ibuprofen gel with levomenthol, and diclofenac gel.;Secondary Objective: The secondary objective of this study is to determine the analgesic efficacy of the three compounds at two hours post treatment.;Primary end point(s): The time to onset of significant pain relief as assessed by the reduction of two points on an 11 point numeric rating scale (NRS).; Timepoint(s) of evaluation of this end point: Patients will complete the NRS (Pain) and warming/cooling scale (WCS) at the following time points: – 1; 2.5; 5; 7.5; 10; 12.5; 15; 20; 25; 30; 40; 50; 60; 75; 90; 105; 120 min | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints for this study are: 1. Assessment of the analgesic efficacy. 2. Assessment of any cooling or warming sensations experienced by the patient 3. Assessment of any change in functional impairment 4. Assessment of any general pain relief as reported by the patient ; Timepoint(s) of evaluation of this end point: 1. To assess the analgesic efficacy at two hours. 2. To assess any cooling or warming sensations experienced by the patient 3. To assess any change in functional impairment 4. To assess any general pain relief as reported by the patient at 2 hours | — |
Countries
United Kingdom
Contacts
Public ContactDr Gordon Crawford
CPS Research and Patients Direct
Outcome results
None listed