Trial record 13 of 29 for:    Open Studies | "Ankle Injuries"

Efficacy of Topical Indomethacin Patch Over Placebo in Ankle Sprain Pain Relief

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by GlaxoSmithKline
Sponsor:
Collaborator:
Rundo International Pharmaceutical Research & Development Co.,Ltd.
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01957215
First received: October 4, 2013
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

This study will investigate the efficacy of the Indomethacin patch in pain relief of ankle sprain in adult patients, compared to a placebo patch


Condition Intervention Phase
Ankle Sprain
Drug: Indomethacin
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Clinical Study to Assess the Efficacy of Pain Relief of Topical Indomethacin Patch Over Placebo in Ankle Sprain Patients

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Sum of Pain Intensity Difference (SPID) [ Time Frame: From treatment Day 1 to Day 3 ] [ Designated as safety issue: No ]
    Assessing efficacy of Indomethacin patch in comparison with placebo patch measured by SPID for pain on movement during the 48 hour time interval.


Secondary Outcome Measures:
  • Pain Relief Score (PRS) [ Time Frame: PRS to be assessed Day 1-end of study ] [ Designated as safety issue: No ]
    PRS to be assessed.

  • Numerical Rating Scale (NRS) for pain [ Time Frame: NRS on movement Day 1-end of study ] [ Designated as safety issue: No ]
    NRS for pain on movement (walking 5 steps on flat surface) to be assessed.

  • Change from baseline in NRS at rest [ Time Frame: NRS at rest Day1-Day7 ] [ Designated as safety issue: No ]
    Measuring the mean changes from baseline of NRS at rest twice daily (in the morning and afternoon) from treatment day 1 to day 7 between treatment groups.

  • Time to onset of pain relief [ Time Frame: Day 1-2 ,Day 1-3, Day 1-7 ] [ Designated as safety issue: No ]
    Time to reach PRS=1; "A little or perceptible pain relief".

  • SPID [ Time Frame: Day 1-2 ,Day 1-3, Day 1-7 ] [ Designated as safety issue: No ]
    SPID (1-2days), SPID (1-7days) to be assessed.

  • Sum of Pain Intensity Difference and Pain Relief (SPRID) [ Time Frame: Day 1-2 ,Day 1-3, Day 1-7 ] [ Designated as safety issue: No ]
    SPRID to be assessed

  • Total Pain Relief (TOTPAR) [ Time Frame: Day 1-2 ,Day 1-3, Day 1-7 ] [ Designated as safety issue: No ]
    TOTPAR at treatment 1 to 2, 1 to 3, and 1 to 7 days time period between treatment groups.

  • Time to rescue medication [ Time Frame: Day 1 to Day 14 ] [ Designated as safety issue: No ]
    Rescue medication use to be monitored

  • Global Assessment [ Time Frame: End of study ] [ Designated as safety issue: No ]
    Global Assessment to be accessed


Estimated Enrollment: 270
Study Start Date: October 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Indomethacin patch
Indomethacin patch to be applied on the sprained ankle twice a day (BID).
Drug: Indomethacin
Topical indomethacin
Placebo Comparator: Placebo patch
Placebo patch to be applied on the sprained ankle BID.
Drug: Placebo
Placebo patch

Detailed Description:

Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which reduces pain, fever, stiffness and swelling in acute skeletal musculature injuries involving joints. However, oral Indomethacin formulations predisposes for some systemic side effects. To avoid the systemic side effects of oral Indomethacin, a topical Indomethacin formulations have been developed and approved in some countries as an Over the counter product. Present study is to investigate the efficacy of the Indomethacin patch in pain relief of ankle sprain in adult patients.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant with Grade I or Grade II acute sprain of the lateral ankle within 24 hours before screening visit
  • Participant with self-assessed pain intensity score after movement (5 steps) at the site of the ankle sprain that is >= 5 as measured on a 0-10 NRS rating.
  • Participant with a peri-malleolar edema (sub-malleolar perimeter difference of >=20mm between injured and uninjured ankle)

Exclusion Criteria:

  • Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
  • Participant who had medication that could interfere with the subject's perception of pain since experiencing ankle sprain.
  • Pregnancy , Breast Feeding and Substance Abuse
  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: NCT01957215

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Locations
China, Jiangsu
Changzhou NO.2 People?s Hospital Recruiting
Changzhou, Jiangsu, China, 213003
Contact: US GSK Clinical Trials Call Center    877-379-3718    info@GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    info@GSKClinicalSupportHD@gsk.com   
Changzhou NO.2 People's Hospital Recruiting
Changzhou, Jiangsu, China, 213003
Contact: US GSK Clinical Trials Call Center    877-379-3718    info@GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    info@GSKClinicalSupportHD@gsk.com   
Zhongda Hospital Southeast University Recruiting
Nanjing, Jiangsu, China, 210009
Contact: US GSK Clinical Trials Call Center    877-379-3718    info@GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    info@GSKClinicalSupportHD@gsk.com   
The First Affiliated Hospital of Soochow University Recruiting
Suzhou, Jiangsu, China, 215006
Contact: US GSK Clinical Trials Call Center    877-379-3718    info@GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    info@GSKClinicalSupportHD@gsk.com   
China, Shanghai
Shanghai Xuhui Centre Hospital Terminated
Shanghai, Shanghai, China, 200031
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200092
Contact: US GSK Clinical Trials Call Center    877-379-3718    info@GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    info@GSKClinicalSupportHD@gsk.com   
Shanghai First People?s Hospital Recruiting
Shanghai, Shanghai, China, 201620
Contact: US GSK Clinical Trials Call Center    877-379-3718    info@GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    info@GSKClinicalSupportHD@gsk.com   
Shanghai Ruijin Hospital Recruiting
Shanghai, Shanghai, China, 200025
Contact: US GSK Clinical Trials Call Center    877-379-3718    info@GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    info@GSKClinicalSupportHD@gsk.com   
Shanghai East Hospital Recruiting
Shanghai, Shanghai, China, 200120
Contact: US GSK Clinical Trials Call Center    877-379-3718    info@GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    info@GSKClinicalSupportHD@gsk.com   
Shanghai Tenth People?s Hospital Recruiting
Shanghai, Shanghai, China, 200072
Contact: US GSK Clinical Trials Call Center    877-379-3718    info@GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    info@GSKClinicalSupportHD@gsk.com   
Ruijin Hospital Luwan Branch Recruiting
Shanghai, Shanghai, China, 200020
Contact: US GSK Clinical Trials Call Center    877-379-3718    info@GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    info@GSKClinicalSupportHD@gsk.com   
Sponsors and Collaborators
GlaxoSmithKline
Rundo International Pharmaceutical Research & Development Co.,Ltd.
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01957215     History of Changes
Other Study ID Numbers: RH01778
Study First Received: October 4, 2013
Last Updated: July 10, 2014
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 23, 2014