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Pilot Study Comparing the Efficacy and Safety of a New Pain Patch and Placebo in Delayed Onset Muscle Soreness (DOMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02602353
Recruitment Status : Completed
First Posted : November 11, 2015
Last Update Posted : October 28, 2016
Sponsor:
Collaborator:
Cardinal Health
Information provided by (Responsible Party):
Lead Chemical Co., Ltd.

Brief Summary:
The purpose of this study is to evaluate the analgesic efficacy and safety of a new pain patch compared to placebo and no treatment in subjects experiencing Delayed Onset Muscle Soreness (DOMS).

Condition or disease Intervention/treatment Phase
Delayed Onset Muscle Soreness Drug: Loxoprofen Pain Patch Drug: Placebo Patch Drug: No Treatment Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Parallel-Group and Placebo-Controlled Pilot Study to Assess the Safety and Efficacy of a New Pain Patch Versus Placebo and No Treatment for the Treatment of Delayed Onset Muscle Soreness (DOMS)
Study Start Date : October 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Arm Intervention/treatment
Experimental: Loxoprofen Pain Patch
One Active Pain Patch containing loxoprofen applied once daily for 3 days
Drug: Loxoprofen Pain Patch
One Loxoprofen Pain Patch (active NSAID) applied once daily for 3 days

Placebo Comparator: Placebo Patch
One Placebo Patch applied once daily for 3 days
Drug: Placebo Patch
One Placebo Patch applied daily for 3 days

No Treatment
No Treatment for 3 days
Drug: No Treatment
No Treatment for 3 days




Primary Outcome Measures :
  1. Sum of pain intensity differences over 24 hours from baseline (SPID 24) with movement [ Time Frame: 0-24 hours ]

Secondary Outcome Measures :
  1. Sum of pain intensity differences over 24 hours from baseline (SPID 24) at rest [ Time Frame: 0-24 hours ]
  2. Sum of pain intensity differences over 48 hours from baseline (SPID 48) with movement [ Time Frame: 0-48 hours ]
  3. Sum of pain intensity differences over 48 hours from baseline (SPID 48) at rest [ Time Frame: 0-48 hours ]
  4. Time to onset of first perceptible pain relief [ Time Frame: First 4 hours after Dose 1 ]
  5. Time to onset of meaningful pain relief [ Time Frame: First 4 hours after Dose 1 ]
  6. Subjects global impression of medication [ Time Frame: Day 10 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males or females, 18 to 40 years of age
  • are in good general health, with a BMI less than or equal to 32, and able to perform the exercise regimen
  • develops muscle pain/soreness within 24-48 hours of the end of the exercise regimen and have a baseline muscle pain/soreness with movement of greater than or equal to 5 on the Numerical Rating Scale (NRS) (numerical rating scale) and at least "moderate" on the categorical scale

Exclusion Criteria:

  • has engaged in upper extremity exercise for a minimum of 6 months prior to study participation
  • has been working heavy manual or physical labor jobs within 3 months prior to study participation.
  • has a known history of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, or any nonsteroidal anti-inflammatory drugs
  • has skin lesions such as psoriasis at the application site
  • has abnormal skin condition such as eczema, contact dermatitis, pigment anomaly, etc.
  • has an allergy-related skin condition

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02602353


Locations
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United States, Utah
Jean Brown Research
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
Lead Chemical Co., Ltd.
Cardinal Health
Investigators
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Principal Investigator: Derek Muse, MD Jean Brown Research
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Responsible Party: Lead Chemical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02602353    
Other Study ID Numbers: LEAD-PhII-050
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: October 28, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Myalgia
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Musculoskeletal Pain
Pain
Neurologic Manifestations
Loxoprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents