5% Topical Ibuprofen (IBU) for Ankle Sprain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01945034
First received: June 21, 2013
Last updated: March 26, 2015
Last verified: March 2015
  Purpose

This study is being conducted to evaluate the effects of IBU 5% Topical Gel versus topical placebo for the relief of pain associated with a first or second degree ankle sprain. Both twice daily and three times daily regimens will be evaluated.


Condition Intervention Phase
Ankle Injuries
Drug: Topical IBU twice daily
Drug: Placebo twice daily
Drug: Topical IBU three times daily
Drug: Placebo three times daily
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Placebo-controlled, Double-blind Evaluation Of The Efficacy And Safety Of Ibuprofen 5% Topical Gel For The Treatment Of Ankle Sprain

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Sum of pain intensity difference on weight bearing over 24 hours after first dose [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Sum of pain intensity difference on weight bearing over 3 days [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sum of pain intensity difference at rest over 24 hours [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Subject Global Assessment of Ankle Injury [ Time Frame: Days 3 and 10 ] [ Designated as safety issue: No ]
  • Physician Global Assessment of Ankle Injury [ Time Frame: Days 3 and 10 ] [ Designated as safety issue: No ]
  • Ankle Pain at Rest [ Time Frame: Each post-dose time point through 7 days ] [ Designated as safety issue: No ]
  • Ankle Pain Upon Weight Bearing [ Time Frame: Each post-dose timepoing through 7 days ] [ Designated as safety issue: No ]
  • Time weighted sum of pain intensity difference at rest [ Time Frame: Over 6 hours on Day 1 and over 2 hours on Day 3 ] [ Designated as safety issue: No ]
  • Time weighted sum of pain intensity difference upon weight bearing [ Time Frame: Over 6 hours on Day 1 and over 2 hours on Day 3 ] [ Designated as safety issue: No ]
  • Time weighted pain intensity difference score [ Time Frame: Over each day, over 3 days, over 7 days ] [ Designated as safety issue: No ]
  • Subject assessment of normal function and activity [ Time Frame: Days 3 and 10 ] [ Designated as safety issue: No ]
  • Subject Global Assessment of Medication [ Time Frame: Day 10 ] [ Designated as safety issue: No ]
  • Time to onset of first perceptible relief [ Time Frame: First 6 hours after Dose 1 ] [ Designated as safety issue: No ]
  • Time to onset of meaningful relief [ Time Frame: First 6 hours after Dose 1 ] [ Designated as safety issue: No ]
  • Time to rescue medication after initial dose, and after each subsequent dose provided that at least 25% of subjects take rescue medication [ Time Frame: 10 days ] [ Designated as safety issue: No ]
  • Number of doses of rescue medication used [ Time Frame: First 7 days of dosing ] [ Designated as safety issue: No ]
  • Percentage of subjects taking rescue medication [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Enrollment: 305
Study Start Date: November 2013
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Topical IBU twice daily Drug: Topical IBU twice daily
Topical gel administered as 4 inch strip twice daily for 7 days, and as needed for an additional 3 days
Placebo Comparator: Placebo twice daily Drug: Placebo twice daily
Topical gel administered as a 4 inch strip twice daily for 7 days, and as needed for an additional 3 days
Experimental: Topical IBU three times daily Drug: Topical IBU three times daily
Topical gel administered as a 4 inch strip three times daily for 7 days, and as needed for additional 3 days
Placebo Comparator: Placebo three times daily Drug: Placebo three times daily
Topical gel administered as a 4 inch strip three times daily for 7 days, and as needed for additional 3 days

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • First or second degree ankle sprain within 48 hours of first dose of study medication
  • Medically cleared to participate

Exclusion Criteria:

  • Similar injury of same joint within last 6 months
  • Requires bed rest, surgery, or over-the-counter or prescription analgesics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01945034

Locations
United States, Alabama
Helen Keller Hospital
Sheffield, Alabama, United States, 35660
United States, Arizona
Visions Clinical Research - Tucson
Tucson, Arizona, United States, 85712
United States, California
Orange County Research Institute
Anaheim, California, United States, 92801
eStudySite, La Mesa
La Mesa, California, United States, 91942
eStudySite, Inc.
Oceanside, California, United States, 92056
San Diego Sports Medicine and Family Health Center
San Diego, California, United States, 92120
United States, Florida
L&L Research Choices
Miami, Florida, United States, 33144
Sunrise Research Institute, Inc.
Miami, Florida, United States, 33130
Doctors Research Network
South Miami, Florida, United States, 33143
United States, Idaho
Elite Clinical Trials LLLP
Blackfoot, Idaho, United States, 83221
United States, Louisiana
MedPharmics, LLC
Metairie, Louisiana, United States, 70006
United States, Nebraska
Heartland Clinical Research, Inc.
Omaha, Nebraska, United States, 68134
Quality Clinical Research, Inc.
Omaha, Nebraska, United States, 68114
United States, North Carolina
PMG Research of Salisbury
Salisbury, North Carolina, United States, 28144
United States, North Dakota
Lillestol Research, LLC
Fargo, North Dakota, United States, 58103
United States, Texas
Clinical Trial Network
Houston, Texas, United States, 77074
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States, 78229
Sports Medicine Associates of San Antonio
San Antonio, Texas, United States, 78240
United States, Virginia
Danville Orthopedic Clinic
Danville, Virginia, United States, 24541
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01945034     History of Changes
Other Study ID Numbers: B3491009
Study First Received: June 21, 2013
Last Updated: March 26, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
topical ibuprofen
ankle sprain

Additional relevant MeSH terms:
Ankle Injuries
Leg Injuries
Wounds and Injuries
Ibuprofen
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 30, 2015