5% Topical Ibuprofen (IBU) for Ankle Sprain

NCT01945034 | Completed Phase 3 Results

• 1 other identifier: B3491009
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 19

Brief Summary

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.

Conditions

Ankle Injuries

Keywords

topical ibuprofen; ankle sprain

Outcome Measures

Primary Outcomes (2)

• Sum of Pain Intensity Difference (SPID) on Weight Bearing Over 3 Days (SPID WB0-3)

  PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. Pain intensity difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 3 days (72 hours). Total score ranges from -360 (higher pain relief) to 432 (lower pain relief) for SPID WB0-3. SPID is a value of change from baseline and as pain score at base line is usually higher than that at post baseline, a negative value of SPID indicates higher pain relief from baseline.

  Over 3 Days (0-72 hours)

• Sum of Ankle Pain Intensity Difference on Weight Bearing Over 24 Hours After Dose 1 (SPID WB24)

  PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 24 hours. Total score ranges from -120 (higher pain relief) to 144 (lower pain relief) for SPID WB24. SPID is a value of change from baseline. Pain score at base line is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while a positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline.

  0 to 24 hours

Secondary Outcomes (13)

• Sum of Pain Intensity Difference at Rest Over 24 Hours on Day 1 (SPID R24)

  0 to 24 hours

• Change From Baseline in Participant's Global Assessment of Ankle Injury at Day 3 and 10

  Baseline, Day 3, 10

• Change From Baseline in Physician Global Assessment of Ankle Injury at Day 3 and 10

  Baseline, Day 3, 10

• Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points

  Baseline, 1, 2, 3, 4, 5, 6, 12(Day1),24(Day2),30(Day2),36(Day2),48(Day3),50(Day3),54(Day3),60(Day3),72(Day4),78(Day4),84(Day4), 96(Day5),102(Day5), 108 (Day5), 120(Day6),126(Day6),132(Day6),144(Day7),150(Day7),156(Day7) hours post first dose on Day 1

• Sum of Pain Intensity Difference at Rest and on Weight Bearing Over 6 Hours on Day 1 and Over 2 Hours on Day 3

  Over 6 hours on Day 1, over 2 hours on Day 3

Study Arms (4)

Topical IBU twice daily

EXPERIMENTAL

Drug: Topical IBU twice daily

Placebo twice daily

PLACEBO COMPARATOR

Drug: Placebo twice daily

Topical IBU three times daily

EXPERIMENTAL

Drug: Topical IBU three times daily

Placebo three times daily

PLACEBO COMPARATOR

Drug: Placebo three times daily

Interventions

Topical IBU twice daily DRUG

Topical gel administered as 4 inch strip twice daily for 7 days, and as needed for an additional 3 days

Topical IBU twice daily

Placebo twice daily DRUG

Topical gel administered as a 4 inch strip twice daily for 7 days, and as needed for an additional 3 days

Placebo twice daily

Topical IBU three times daily DRUG

Topical gel administered as a 4 inch strip three times daily for 7 days, and as needed for additional 3 days

Topical IBU three times daily

Placebo three times daily DRUG

Topical gel administered as a 4 inch strip three times daily for 7 days, and as needed for additional 3 days

Placebo three times daily

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Similar injury of same joint within last 6 months
• Requires bed rest, surgery, or over-the-counter or prescription analgesics

Sponsors & Collaborators

• Pfizer: lead

Study Sites (19)

Helen Keller Hospital

Sheffield, Alabama, 35660, United States

Location

Visions Clinical Research - Tucson

Tucson, Arizona, 85712, United States

Location

Orange County Research Institute

Anaheim, California, 92801, United States

Location

eStudy Site

San Diego, California, 92120, United States

Location

San Diego Sports Medicine and Family Health Center

San Diego, California, 92120, United States

Location

Sunrise Research Institute, Inc.

Miami, Florida, 33130, United States

Location

L&L Research Choices

Miami, Florida, 33144, United States

Location

Doctors Research Network

South Miami, Florida, 33143, United States

Location

Elite Clinical Trials LLLP

Blackfoot, Idaho, 83221, United States

Location

MedPharmics, LLC

Metairie, Louisiana, 70006, United States

Location

Quality Clinical Research, Inc.

Omaha, Nebraska, 68114, United States

Location

Heartland Clinical Research, Inc.

Omaha, Nebraska, 68134, United States

Location

PMG Research of Salisbury

Salisbury, North Carolina, 28144, United States

Location

Lillestol Research, LLC

Fargo, North Dakota, 58103, United States

Location

Clinical Trial Network

Houston, Texas, 77074, United States

Location

Clinical Trials of Texas, Inc.

San Antonio, Texas, 78229, United States

Location

Clinical Trials of Texas

San Antonio, Texas, 78229, United States

Location

Sports Medicine Associates of San Antonio

San Antonio, Texas, 78240, United States

Location

Danville Orthopedic Clinic

Danville, Virginia, 24541, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: June 21, 2013
• First Posted: September 18, 2013
• Study Start: November 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: May 26, 2016
• Results First Posted: May 26, 2016

Record last verified: 2016-04

Locations

US (19)