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

NCT02602353 | Completed Phase 2

• 1 other identifier: LEAD-PhII-050
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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).

Conditions

Delayed Onset Muscle Soreness

Outcome Measures

Primary Outcomes (1)

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

  0-24 hours

Secondary Outcomes (6)

• Sum of pain intensity differences over 24 hours from baseline (SPID 24) at rest

  0-24 hours

• Sum of pain intensity differences over 48 hours from baseline (SPID 48) with movement

  0-48 hours

• Sum of pain intensity differences over 48 hours from baseline (SPID 48) at rest

  0-48 hours

• Time to onset of first perceptible pain relief

  First 4 hours after Dose 1

• Time to onset of meaningful pain relief

  First 4 hours after Dose 1

Study Arms (3)

Loxoprofen Pain Patch

EXPERIMENTAL

One Active Pain Patch containing loxoprofen applied once daily for 3 days

Drug: Loxoprofen Pain Patch

Placebo Patch

PLACEBO COMPARATOR

One Placebo Patch applied once daily for 3 days

Drug: Placebo Patch

No Treatment

OTHER

No Treatment for 3 days

Drug: No Treatment

Interventions

Loxoprofen Pain Patch DRUG

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

Loxoprofen Pain Patch

Placebo Patch DRUG

One Placebo Patch applied daily for 3 days

Placebo Patch

No Treatment DRUG

No Treatment for 3 days

No Treatment

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lead Chemical Co., Ltd.: lead
• Cardinal Health: collaborator

Study Sites (1)

Jean Brown Research

Salt Lake City, Utah, 84124, United States

Location

Study Officials

• Derek Muse, MD

  Jean Brown Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2015
• First Posted: November 11, 2015
• Study Start: October 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 28, 2016

Record last verified: 2016-10

Locations

US (1)