Etodolac-lidocaine Patch in Subjects Experiencing Acute Delayed Onset Muscle Soreness
Completed · Phase 3 · Has a placebo group
Conditions studied: Acute Delayed Onset Muscle Soreness (DOMS)
In brief
This study evaluate the efficacy and safety of Etodolac-lidocaine topical patch applied one time daily when compared with placebo in the treatment of acute Delayed Onset Muscle Soreness (DOMS) of the upper limbs.
Key facts
- Study ID
- NCT02695381
- Run by
- MEDRx USA, Inc.
- People needed
- 100
- Starts
- 2016-03-01
- Expected to finish
- 2016-09-01
- Last updated by the study team
- 2016-09-12
Who can join
Age: 18 and older, up to 35. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Have not engaged in significant upper extremity fitness activities for more than two times per week for ≥ 2 consecutive weeks in the past 6 months prior to screening.
- Subject has a body mass index of between 18 and 30 kg/m2, inclusive.
- Subjects who report a pain with movement score in both arms of at least 5 (based on a 0-10 NRS) secondary to DOMS approximately 24 to 30 hours after each arm was exercised.
You may not qualify if…
- Presence of another painful physical condition that, in the opinion of the Investigator, may confound study assessments.
- Use of pain medication (including anti-inflammatory drugs) prior to the Exercise Visit until 72 hours after randomization.
- Use of any corticosteroids (oral, injectable, topical, inhaled) from before the Exercise Visit until randomization. Corticosteroids must be washed out by at least 3 days before the Exercise Visit.
- Chronic or acute renal or hepatic disorder, inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis) or a significant coagulation defect.
- History of allergy (cutaneous or systemic), asthma, hypersensitivity to any of the following: etodolac, lidocaine, paracetamol (acetaminophen), acetylsalicylic acid, salicylic acid, other NSAID, other local anesthetic, known intolerance (cutaneous or systemic) to any of the ingredients in the patch.
Where it is running
- Lotus Clinical Research — Pasadena, California, United States
Full record on ClinicalTrials.gov
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