5% Topical Ibuprofen (IBU) for Ankle Sprain

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01945034
First received: June 21, 2013
Last updated: August 12, 2014
Last verified: August 2014
  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 ]

Estimated Enrollment: 340
Study Start Date: September 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (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

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

Locations
United States, Alabama
Pfizer Investigational Site Recruiting
Sheffield, Alabama, United States, 35660
United States, Arizona
Pfizer Investigational Site Recruiting
Tucson, Arizona, United States, 85712
United States, California
Pfizer Investigational Site Recruiting
Anaheim, California, United States, 92801
Pfizer Investigational Site Recruiting
Carmichael, California, United States, 95608
Pfizer Investigational Site Recruiting
Fair Oaks, California, United States, 95628
Pfizer Investigational Site Recruiting
La Mesa, California, United States, 91942
Pfizer Investigational Site Not yet recruiting
National City, California, United States, 91950
Pfizer Investigational Site Recruiting
Oceanside, California, United States, 92056
Pfizer Investigational Site Recruiting
San Diego, California, United States, 92120
United States, Florida
Pfizer Investigational Site Recruiting
Miami, Florida, United States, 33130
Pfizer Investigational Site Recruiting
Miami, Florida, United States, 33144
Pfizer Investigational Site Recruiting
South Miami, Florida, United States, 33143
United States, Idaho
Pfizer Investigational Site Recruiting
Blackfoot, Idaho, United States, 83221
United States, Louisiana
Pfizer Investigational Site Recruiting
Metairie, Louisiana, United States, 70006
United States, Nebraska
Pfizer Investigational Site Recruiting
Omaha, Nebraska, United States, 68134
Pfizer Investigational Site Recruiting
Omaha, Nebraska, United States, 68114
United States, North Carolina
Pfizer Investigational Site Recruiting
Salisbury, North Carolina, United States, 28144
United States, North Dakota
Pfizer Investigational Site Recruiting
Fargo, North Dakota, United States, 58103
United States, Texas
Pfizer Investigational Site Recruiting
Houston, Texas, United States, 77074
Pfizer Investigational Site Not yet recruiting
Houston, Texas, United States, 77098
Pfizer Investigational Site Not yet recruiting
Houston, Texas, United States, 77062
Pfizer Investigational Site Recruiting
San Antonio, Texas, United States, 78240
Pfizer Investigational Site Recruiting
San Antonio, Texas, United States, 78229
Pfizer Investigational Site Not yet recruiting
Sugar Land, Texas, United States, 77479
Pfizer Investigational Site Not yet recruiting
Webster, Texas, United States, 77598
United States, Virginia
Pfizer Investigational Site Recruiting
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: August 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
topical ibuprofen
ankle sprain

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

ClinicalTrials.gov processed this record on August 20, 2014