NCT02324985

Brief Summary

This study is designed to evaluate the analgesic safety and efficacy of study drug (AP0302) applied topically every 6 hours as compared to a vehicle, in subjects experiencing delayed onset muscle soreness.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147

participants targeted

Target at P50-P75 for phase_2 pain

Timeline
Completed

Started Jan 2015

Typical duration for phase_2 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 24, 2014

Completed
8 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

February 25, 2019

Status Verified

January 1, 2019

Enrollment Period

6 months

First QC Date

December 19, 2014

Last Update Submit

February 21, 2019

Conditions

PainDelayed Onset Muscle Soreness

Keywords

muscle soreness

Outcome Measures

Primary Outcomes (1)

  • Sum of pain intensity differences over 24 hours from baseline (SPID24) with movement

    SPID 24

    0-24 hours

Secondary Outcomes (2)

  • Sum of pain intensity differences over 48 hours from baseline (SPID48) with movement

    0-48 hours

  • Sum of pain intensity differences over 48 hours from baseline (SPID48) at rest

    0-48 hours

Study Arms (2)

Active Arm

ACTIVE COMPARATOR

S-Ibuprofen Topical Gel 5%

Drug: S-Ibuprofen Topical Gel 5%

Placebo Arm

PLACEBO COMPARATOR

Vehicle Topical Gel

Drug: Vehicle Topical Gel

Interventions

S-Ibuprofen Topical Gel 5%DRUG

S-Ibuprofen Topical Gel 5% applied every 6 hours

Also known as: Active Gel
Active Arm
Vehicle Topical GelDRUG

Vehicle Topical Gel applied every 6 hours

Also known as: Vehicle Gel
Placebo Arm

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • no clinically significant medical conditions
  • BMI between 18-30
  • negative drug, alcohol, pregnancy screens

You may not qualify if:

  • no upper extremity workout in last 6 months
  • no job requiring heavy lifting
  • history of muscle disorders
  • allergy or intolerance to study drug
  • history of recent pain medication use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lotus Clinical Research, LLC

Pasadena, California, 91105, United States

Location

MeSH Terms

Conditions

PainMyalgia

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesMusculoskeletal Pain

Study Officials

  • Sonia Singla, DO

    Lotus Clinical Research

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 19, 2014

First Posted

December 24, 2014

Study Start

January 1, 2015

Primary Completion

July 1, 2015

Study Completion

June 1, 2016

Last Updated

February 25, 2019

Record last verified: 2019-01

Locations

US(1)