Pain and inflammation due to Grade I or Grade II acute sprain of the lateral ankle MedDRA version: 17.0 Level: PT Classification code 10061218 Term: Inflammation System Organ Class: 10018065 - General disorders and administration site conditions MedDRA version: 17.0 Level: PT Classification code 10033371 Term: Pain System Organ Class: 10018065 - General disorders and administration site conditions MedDRA version: 17.0 Level: PT Classification code 10024453 Term: Ligament sprain System Organ C
Conditions
Interventions
Product Name: Diclofenac sodium/menthol gel
Product Code: MFC51123
Pharmaceutical Form: Gel
INN or Proposed INN: DICLOFENAC SODIUM
Other descriptive name: DICLOFENAC SODIUM
Concentration unit: % (W/W)
Sponsors
GlaxoSmithKline Consumer Healthcare
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Consent: Subject demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form. 2. Age: Subject is from 16 to 65 years of age. 3. Compliance: Subject understands and is willing, able and likely to comply with all study procedures and restrictions. 4. General Health: Subject is in good general and mental health with, in the opinion of the investigator or medically qualified designee: a) No clinically significant and relevant abnormalities of medical history or physical examination. b) No condition that would impact on the subject’s safety or wellbeing or affect his or her ability to understand and follow study procedures and requirements. 5. Diagnosis: a) Subject has a Grade I or Grade II acute sprain of the lateral ankle within 24 hours of Visit 1 b) Subject has self-assessed pain intensity at the site of the ankle sprain that is = 5 as measured on an 11-point numerical rating scale c) Subject has a peri-malleolar edema (sub-malleolar perimeter difference of = 20mm between injured and uninjured ankle 6. Contraception: Females of childbearing potential who are, in the opinion of the investigator, practicing a reliable method of contraception. For the purposes of this study, reliable contraception is defined as abstinence, oral contraceptive, either combined or progestogen alone OR injectable progestogen OR implants of levonorgestrel OR estrogenic vaginal ring OR percutaneous contraceptive patches OR intrauterine device or intrauterine system OR double barrier method (condom or occlusive cap [diaphragm or cervical vault caps] plus spermicidal agent [foam, gel, film, cream, suppository]) OR male partner sterilization prior to the female subject's entry into the study, and this male is the sole partner for that subject. Are the trial subjects under 18? yes Number of subjects for this age range: 40 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 360 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnancy: Women who are pregnant or who have a positive urine pregnancy test. 2. Breast-feeding: Women who are breast–feeding. 3. Subject has treated the ankle sprain with treatment such as oral or other topical pain relief medications, massage or physical therapy since experiencing the ankle sprain. The application of ice to the affected ankle prior to visit 1 is allowed. 4. Subject has other acute or chronic pain disorders, which may confound the study pain evaluations. 5. Subject suffered from a grade I-III ankle sprain at the same ankle or any other significant injuries (based on investigator’s judgment), or surgeries at the same ankle or foot within 30 days from the current injury. Pain and instability exist at the same ankle due to previous sprain or other trauma. Ligament hyperlaxity occuring at the same ankle due to connective tissue diseases, e.g. Marfan’s syndrome, Down’s syndrome, Ehlers-Danlos Syndrome, etc. 6. Subject has injury to both ankles or to both medial and lateral ligaments of the same ankle. 7. Allergy/Intolerance: Subject has known or suspected hypersensitivity, allergy, intolerance or contraindication to the use of any of the study medications (or closely related compounds), any of their stated ingredients or any topical medications before. 8. Subject is currently taking or has taken within the previous three months medications or herbal supplements likely, on available evidence, to interfere with the validity of subject-rated assessments. 9. Subject has a medical history of renal or hepatic disease, a current active peptic ulcer or a history of upper gastrointestinal bleeding or perforation related to previous NSAID therapy. 10. Clinical Study/Experimental Medication: a) Subject has participated in another clinical study or received an investigational drug within 30 days of Visit 1. b) Subject has previously participated in this study. 11. Substance abuse: Subject has a recent history (within the last 2 years) of alcohol or other substance abuse. 12. Personnel: Subject is an employee of the sponsor or the study site or members of their immediate family.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess efficacy of MFC51123 gel over placebo as measured by Area Under the Curve of Pain Intensity on Movement (walking 5 steps on flat surface) for the period from 24 to 72 hours of treatment (AUC1-3days).;Secondary Objective: Please see secondary endpoints detailed in section E.5.2.;Primary end point(s): To assess efficacy of MFC51123 gel over placebo as measured by Area Under the Curve of Pain Intensity on Movement (walking 5 steps on flat surface) for the period from 24 to 72 hours of treatment (AUC1-3days).;Timepoint(s) of evaluation of this end point: Period from 24 to 72 hours of treatment (AUC1-3days). | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Timepoints of evaluation for each of the secondary endpoints are detailed in the section above.;Secondary end point(s): ? To compare the effect on AUC1-3days of MFC51123 gel vs. 1% diclofenac sodium gel and vs. 3% menthol gel; 1% diclofenac sodium gel vs. 3% menthol gel and vs. Placebo. ? To assess pain relief as measured by pain relief score (PRS), as well as pain intensity as measured by Numerical Rating Scale (NRS) scores for pain on movement and pain at rest at 10, 30, 60 minutes and 4, 6, 12, 18 and 24 hours of treatment and twice daily from 2nd to 10th day of treatment. ? To compare time to onset of pain relief as measured by time to reach “a little” or “perceptible” pain relief (PRS = 1) confirmed by meaningful pain relief (PRS = 2) at the same time points as PRS/NRS. ? To assess Sum of Pain Intensity Difference (SPID), Pain Intensity Difference (PID) and Total Pain Relief (TOTPAR) for periods 0 - 6, 0 - 12 hours and 0 to 1, 1 to 3, and 0 to 7 days after initial treatment between treatment groups. ? To compare time to onset and the duration of cooling and soothing sensations among treatments in the first 6 hour time-period post-first dose (at 10, 30, 60 minutes, 4 and 6 hours after initial treatment). ? To compare the skin temperature of the sprained ankle at baseline (just prior to treatment) and at scheduled intervals (at 10, 30, 60 minutes, 4 and 6 hours after initial treatment) in 20% of subjects in Stratum 2 [18-65 year old subjects]. ? To compare the thermal images of the sprained ankle at baseline (just prior to treatment) and at scheduled intervals (1, 4 and 6 hours post initial treatment) of 20% of the skin temperature sub-group subjects (4% of subjects in each treatment group) by FLIR camera. ? To compare the proportion of subjects with “a little” or “perceptible” pain relief (PRS = 1) confirmed by meaningful relief at 6, 12 and 18 hours, and 1, 2 and 3 days after initial treatment. ? To | — |
Countries
Germany
Contacts
Public ContactGSK CH Clinical Trials
GlaxoSmithKline Consumer Healthcare
Outcome results
None listed