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Completed

NCT Number: NCT02602353

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

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).

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Key information

Conditions

Delayed Onset Muscle Soreness

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Jean Brown Research

Salt Lake City, Utah, 84124, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Loxoprofen Pain Patch

Drug

One Loxoprofen Pain Patch (active NSAID) applied once daily for 3 days

Placebo Patch

Drug

One Placebo Patch applied daily for 3 days

no treatment

Drug

No Treatment for 3 days

Primary outcomes

  1. Sum of pain intensity differences over 24 hours from baseline (SPID 24) with movement

    Time frame: 0-24 hours

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Lead Chemical Co., Ltd.

Industry

Collaborators

  • Cardinal Health

Registry information

Official study 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)

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Nov 11, 2015
Registry last updated
Oct 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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