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

This study has been completed.
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: January 29, 2015
Last verified: January 2015
  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


Enrollment: 270
Study Start Date: October 2013
Study Completion Date: September 2014
Primary Completion Date: September 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

Locations
China, Jiangsu
Changzhou NO.2 People's Hospital
Changzhou, Jiangsu, China, 213003
Changzhou NO.2 People?s Hospital
Changzhou, Jiangsu, China, 213003
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China, 210009
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
China, Shanghai
Ruijin Hospital Luwan Branch
Shanghai, Shanghai, China, 200020
Shanghai East Hospital
Shanghai, Shanghai, China, 200120
Shanghai First People's Hospital
Shanghai, Shanghai, China, 201620
Shanghai First People?s Hospital
Shanghai, Shanghai, China, 201620
Shanghai First Peoples Hospital
Shanghai, Shanghai, China, 201620
Shanghai Ruijin Hospital
Shanghai, Shanghai, China, 200025
Shanghai Tenth People's Hospital
Shanghai, Shanghai, China, 200072
Shanghai Tenth People?s Hospital
Shanghai, Shanghai, China, 200072
Shanghai Tenth Peoples Hospital
Shanghai, Shanghai, China, 200072
Shanghai Xuhui Centre Hospital
Shanghai, Shanghai, China, 200031
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai, China, 200092
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: 202177, RH01778
Study First Received: October 4, 2013
Last Updated: January 29, 2015
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on March 26, 2015