A Clinical Study to Assess the Efficacy and Onset of Pain Relief of Topical MFC51123 Diclofenac-Menthol Gel versus Controls in Ankle Sprai
- Conditions
- Pain and inflammation due to Grade I or Grade II acute sprain of the lateral ankleMedDRA version: 17.0Level: PTClassification code 10061218Term: InflammationSystem Organ Class: 10018065 - General disorders and administration site conditionsMedDRA version: 17.0Level: PTClassification code 10033371Term: PainSystem Organ Class: 10018065 - General disorders and administration site conditionsMedDRA version: 17.0Level: PTClassification code 10024453Term: Ligament sprainSystem Organ Class: 10022117 - Injury, poisoning and procedural complicationsTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2013-000992-33-DE
- Lead Sponsor
- GlaxoSmithKline Consumer Healthcare
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method