Voltaren Emulgel 2% Acute Ankle Sprain Non Inferiority Study
Condition: Pain
MeSH terms: Sprains and Strains; Ankle Injuries
Intervention: Diclofenac diethylamine 2.32% gel; Diclofenac diethylamine 1.16% gel; Placebo
Intervention description: Participants will apply DDEA 2.32% gel topically with the finger tips (for approximately 1 minute) on both sides of affected ankle 5 cm on 200 cm^2 two times daily for 7 days.; Participants will apply DDEA 1.16 % gel topically with the finger tips (for approximately 1 minute) on both sides of affected ankle 5 cm on 200 cm^2 four times daily for 7 days.; Participants will apply Placebo gel topically with the finger tips (for approximately 1 minute) on both sides of affected ankle 5 cm on 200 cm^2 two times daily for 7 days.
Intervention MeSH terms: Diclofenac
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 313.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Ankle sprain; diclofenac diethylamine

Summary:

      The purpose of this study is to evaluate the efficacy and safety of diclofenac diethylamine
      2.32 percent (%) gel applied twice daily versus diclofenac diethylamine 1.16% gel applied
      four times daily for 7 days in participants with acute ankle sprain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant provision of a signed and dated informed consent document indicating that
             the participant has been informed of all pertinent aspects of the study before any
             assessment will be performed.

          -  A participant who is willing and able to comply with scheduled visits, treatment plan
             and other study procedures.

          -  A participant with acute sprain of the lateral ankle on one side only, Grade I-II.

          -  A participant who had pain-on-movement greater than or equal to (>=) 50 mm on a 100 mm
             VAS.

          -  A participant with injury within the past 24 hours before randomization.

          -  Participant had not taken pain medication within the 24 hours that precedes
             randomization.Treatment by rest, ice, compression, or elevation (RICE) is authorized
             prior to randomization. Stable daily doses of acetylsalicylic acid (less than or equal
             to [<=] 162 mg) taken for at least 30 days prior to the first dose of study medication
             for non-analgesic reasons may be continued for the duration of the study.

          -  A participant in good general and mental health with, in the opinion of the
             investigator or medically qualified designee with no clinically significant/relevant
             abnormalities in medical history or upon physical examination, or condition, that
             would impact the participant's safety, wellbeing or the outcome of the study, if they
             were to participate in the study, or affect the individual's ability to understand and
             follow study procedures and requirements.

          -  Female participant of childbearing potential and at risk for pregnancy must agree to
             use a highly effective method of contraception throughout the study and for 14 days
             after the last dose of assigned treatment.

        Exclusion Criteria:

          -  A participant with Grade I-III sprain of the affected ankle during the past 3 months.

          -  A participant with Grade II-III sprain, any other significant injury (such as fracture
             or torn ligament), or surgery (except for skin or nails) of the affected ankle or foot
             during the past 6 months.

          -  A participant with pain or instability in the affected ankle attributable to previous
             ankle sprain or any other trauma.

          -  A participant with ankle sprain attributable to a known disease affecting the
             ligaments, such as ligament hyperlaxity due to connective tissue diseases (e.g.
             Marfan's syndrome, Down's syndrome, Ehlers-Danlos syndrome).

          -  A participant who has any skin lesion or wound in the area to be treated.

          -  A participant who intent to undergo surgery during time of participation.

          -  A participant who is an employee of the investigational site, either directly involved
             in the conduct of the study or a member of their immediate family; or an employee of
             the investigational site otherwise supervised by the investigator; or, a GSK CH
             employee directly involved in the conduct of the study or a member of their immediate
             family.

          -  A participant with,in the opinion of the investigator or medically qualified designee,
             an acute or chronic medical, including other current acute or chronic pain conditions,
             or psychiatric condition or laboratory abnormality that may increase the risk
             associated with study participation or investigational product administration or may
             interfere with the interpretation of study results and, in the judgment of the
             investigator or medically qualified designee, would make the participant inappropriate
             for entry into this study.

          -  A participant who is a pregnant female.

          -  A participant who is a breastfeeding female.

          -  A participant with known or suspected intolerance or hypersensitivity to the study
             materials (or closely related compounds) or any of their stated ingredients.

          -  A participant who, in the opinion of the investigator or medically qualified designee,
             should not participate in the study.

          -  A participant unwilling or unable to comply with the Lifestyle Considerations below:
             a) No special requirement for food and drink prior to safety laboratory evaluations.
             b) Participants will abstain from caffeine-containing products for 12 hours prior to
             study visit days (except screening/randomization visit). c) Participants will abstain
             from strenuous exercise (e.g. heavy lifting, weight training, calisthenics, aerobics)
             for the duration of the study. Walking at a normal pace will be permitted.

          -  A participant who has made use of prescription, non-prescription, or dietary
             supplements, containing NSAIDs, COX-2 inhibitors and other analgesic treatments within
             7 days or 5 half-lives, whichever is longer, prior to the first dose of
             investigational product and during the study.

          -  A participant with topical analgesics or anti-inflammatory treatment over the previous
             30 days in the area to be treated in the study period.

          -  A participant with evidence of clinically significant laboratory abnormality caused by
             renal disease (Serum creatinine >=1.5 times the upper limit of normal [ULN]), hepatic
             disease (ALT or AST >= 2 times the ULN), or subject with allergic disease at screening
             that may increase the risk associated with study participation.

          -  A participant with history of regular alcohol consumption exceeding 14 drinks per week
             (1 drink = 5 ounces [150 milliliter {mL}] of wine or 12 ounces [360 mL] of beer or 1.5
             ounces [45 mL] of hard liquor) within 6 months of Screening.

          -  A participant who has received treatment with an investigational drug within 30 days
             (or as determined by the local requirement) or 5 half-lives preceding the first dose
             of investigational product (whichever is longer).

          -  A participant who has previously been enrolled in this study.

          -  A participant with any physical impairment that would influence the study's efficacy
             evaluations, in particular POM and the ankle joint function, such as : peripheral or
             central neurological disease, significant back pain, symptomatic osteoarthritis of the
             hips, knees or feet, or any painful conditions of the lower extremities (e.g. painful
             nail, wound, corn, or wart).