An Investigator Initiated, Within-Subject, Proof of Concept Study to Assess the Efficacy and Safety of Voltaren Gel in Subjects With DOMS

NCT ID: NCT02087748

Last Updated: 2014-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2014-05-31

Brief Summary

The purpose of this study is to evaluate analgesic efficacy of Topical Voltaren Gel (diclofenac sodium gel) 1% applied QID compared to Placebo in Subjects Experiencing Delayed Onset Muscle Soreness.

Detailed Description

The purpose of this randomized, double-blind, placebo controlled, within-subject study is to evaluate the efficacy of topical diclofenac sodium gel (DSG) 1% in reducing pain associated with delayed onset muscle soreness (DOMS). Following exercise, subjects reporting significant DOMS received topical DSG 1% applied to 1 leg and placebo applied to the other every 6 hours for 48 hours.

Conditions

Pain; Delayed Onset Muscle Soreness

Keywords

DOMS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1% diclofenac sodium gel

Diclofenac sodium 1% gel 4 grams applied topically Q6 hour for 48 hours

Group Type: ACTIVE_COMPARATOR

1% diclofenac sodium gel

Intervention Type: DRUG

Diclofenac sodium 1% gel 4 grams applied topically Q6 hour for 48 hours

Placebo

Placebo gel 4gm applied topically Q6 hour for 48 hours

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo gel 4gm applied topically Q6 hour for 48 hours

Interventions

1% diclofenac sodium gel

Diclofenac sodium 1% gel 4 grams applied topically Q6 hour for 48 hours

Intervention Type: DRUG

Placebo

Placebo gel 4gm applied topically Q6 hour for 48 hours

Intervention Type: DRUG

Other Intervention Names

Voltaren; Matching placebo

Eligibility Criteria

Inclusion Criteria

• Patients who provide written informed consent prior to enrollment
• Male or female and 18 to 35 years of age.
• Patients who are 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.

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Lotus Clinical Research, LLC

OTHER

Sponsor Role: lead

Responsible Party

Neil Singla

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Neil Singla, MD

Role: PRINCIPAL_INVESTIGATOR

Lotus Clinical Research, LLC

Locations

Lotus Clinical Research, LLC

Pasadena, California, United States

Countries

United States

Other Identifiers

LCR-VOL-01C

Identifier Type: -

Identifier Source: org_study_id