An Investigator Initiated, Within-Subject, Proof of Concept Study to Assess the Analgesic Efficacy and Safety of Voltaren Gel (1% Diclofenac Sodium) Compared to Placebo in Subjects Experiencing Delayed Onset Muscle Soreness

Inclusion Criteria:

- Patients who provide written informed consent prior to enrollment

- Male or female and 18 to 35 years of age.

- Patients who not engaged in regular lower extremity fitness activities for more than
2 times per week for ≥2 consecutive weeks in the past 6 months prior to screening.

- Female patients are eligible only if all of the following apply:

- Not pregnant (subjects of child bearing potential must have a negative beta
human chorionic gonadotropin (β-hCG) pregnancy test at screening);

- Not lactating;

- Not planning to become pregnant within the duration of the study;

- Patients who are willing and capable of understanding and cooperating with the
requirements of the study.

- Patients able to understand and communicate in English.

Randomization Inclusion Criteria:

- Patients who report a DOMS score ≥4 at rest (numerical rating scale of 0 to 10, where
0 is no pain and 10 is worst pain imaginable) secondary to delayed muscle soreness on
both right and left legs. The DOMS scores at rest reported for each leg must be
within 3 points of each other.

- Patients must report a categorical pain rating of moderate to severe for each leg on
a scale of none, mild, moderate, or severe prior to randomization.

Exclusion Criteria:

Patients who report a DOMS score ≥4 at rest (numerical rating scale of 0 to 10, where 0 is
no pain and 10 is worst pain imaginable) secondary to delayed muscle soreness on both
right and left legs. The DOMS scores at rest reported for each leg must be within 3
points of each other.

- Patients must report a categorical pain rating of moderate to severe for each leg on
a scale of none, mild, moderate, or severe prior to randomization.

- Have a body mass index of >32 kg/m2

- History of active or suspected esophageal, gastric, pyloric channel, or duodenal
ulceration or bleeding within 30 days preceding screening.

- Psychiatric disease including major depression, bipolar disorder, or anxiety, or
other medical condition that, in the opinion of the Investigator, would interfere
with the evaluation of study drug efficacy or safety

- History of clinically significant cardiovascular, cerebrovascular, metabolic,
pulmonary, neurological, hematological, autoimmune, psychiatric or endocrine
disorders, including individuals with Type I or Type II diabetes, or other clinically
significant medical condition that, in the opinion of the Investigator, may preclude
safe study participation.

- Have had surgery or scheduled to undergo surgery of the hips or knees within 6 months
prior to screening and/or during the study participation.

- Have significant biomechanical abnormality in the lower extremity that would preclude
study evaluations, such as: peripheral or central neurological disease, significant
back pain; symptomatic osteoarthritis of the hips, knew, or feet, or other painful
conditions of the lower extremities.

- Have any type of orthopedic and/or prosthetic device or any skin abnormalities on the
legs that may interfere with local tolerability.

- Currently taking corticosteroids or topical analgesic or anti inflammatory treatment
whose the duration of action may affect study evaluations.

- Malignancy in the last 5 years, with the exception of nonmetastatic basal cell or
squamous cell carcinoma of the skin that has been surgically cured, or any Stage 1
cancer or carcinoma in situ cured by resection or localized radiation at least 5
years prior to screening with no evidence of recurrence.

- History of allergy (cutaneous or systemic), hypersensitivity, or asthma to any of the
following: diclofenac, paracetamol, acetylsalicylic acid, salicylic acid, other NSAID
or cyclooxygenase 2-specific inhibitor (COXIB) or known intolerance (cutaneous or
systemic) to any of the ingredients in the gel, such as isopropyl alcohol or
propylene glycol.

- History of known narcotic, analgesic, or alcohol abuse.

- Any cognitive impairment that would, in the opinion of the Investigator, preclude
study participation or compliance with study procedures (e.g., Alzheimer's dementia).

- Previously received an investigational product within 30 days before the scheduled
dose of study medication.