Controlled Study to Assess the Efficacy and Safety of S-Ibuprofen Topical Gel 5% (AP0302) in the Treatment of DOMS

NCT03852459 | Completed Phase 2 Results FDA Drug

• 1 other identifier: AP-007
• Study Type: interventional
• Target: 251
• Locations: 1 country
• Sites: 1

Brief Summary

Phase 2 study designed to evaluated analgesic efficacy and safety of S-Ibuprofen Topical Gel 5%

Conditions

Pain, Acute

Outcome Measures

Primary Outcomes (1)

• Sum of the Time-weighted Differences From Baseline in Pain Intensity With Movement(SPIDMOVE) Over 24 Hours Post Time Zero

  The primary efficacy outcome is the sum of the time-weighted differences from baseline in muscle pain/soreness with movement over 0-24 hours post T0 (SPIDMOVE 0-24h), that is the area under the differences from baseline pain/soreness intensity difference curve. The pain intensity differences (PIDs) with movement from time point A to time point B was calculated using the trapezoid rule by subtracting each post-T0 pain score with movement from the pain score with movement at time point Ti. Positive and higher scores indicate greater reduction in pain. Measured by Pain Intensity Numerical Rating Scale (PI-NRS) where 0 = no pain and 10 = worst possible pain at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 20, 24, 26, 28, 30, 32, 34, 36, 40, 44, and 48 hours post-initial IP dose and immediately prior to the subsequent doses of investigational product (IP).

  0-24 hours.

Secondary Outcomes (5)

• SPIDMOVE Over the Following Intervals: 0-6, 6-12, 0-12, 12-24, 24-36, 24-48, 0-36, 36-48 and 0-48 Hours Post-T0.

  From 0-6, 6-12, 0-12, 12-24, 24-36, 0-36, 24-28,36-48, and 0-48 hours post-T0. Time point i included 1, 2, 3, 4, 5, 6 (pre-dose), 7, 8, 9, 10, 11, 12 (pre-dose), 16, 18 (pre-dose), 20, and 24 (pre-dose) hours after the first dose.

• Sum of Time Weighted Differences From Baseline in Muscle Stiffness (SSID) With Movement Over the Interval

  0-6, 6-12, 0-12, 12-24, 24-36, 24-48, 0-36, 36-48, and 0-48 post T0

• Total Relief With Movement (TOTPAR) 0-6 Hours Post Time Zero

  0-6 hours

• Subject Global Assessment of Study Medication Assessed at Approximately 48 Hours Post Time Zero

  48 hours post time zero

• Number of Participants With Treatment-emergent Adverse Events (TEAEs)

  Up to Day 7

Study Arms (2)

Active Arm

EXPERIMENTAL

S-Ibuprofen Topical Gel 5%

Drug: S-Ibuprofen

Placebo Arm

PLACEBO COMPARATOR

Vehicle Topical Gel

Drug: Vehicle

Interventions

S-Ibuprofen DRUG

Topical Gel 5%

Active Arm

Vehicle DRUG

Vehicle Gel

Placebo Arm

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• history of pain/soreness after exercise
• BMI between 18-30
• negative drug, alcohol, pregnancy screens

You may not qualify if:

• upper extremity workout in last 3 months
• job or hobby requiring heavy lifting
• history of muscle disorders
• allergy or intolerance to NSAID or study drug
• history of recent pain medication use

Sponsors & Collaborators

• Aponia Laboratories, Inc.: lead

Study Sites (1)

JBR Clinical Research

Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Kenneth Corroon
• Organization: Aponia Labs

kcorroon@aponialabs.com

917-574-5335

Study Officials

• Todd Bertoch, MD

  JBR Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: active gel and matching vehicle control gel
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: February 25, 2019
• Study Start: January 12, 2018
• Primary Completion: April 4, 2019
• Study Completion: April 11, 2019
• Last Updated: January 25, 2022
• Results First Posted: January 25, 2022

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)