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Efficacy and Safety of Diclofenac Potassium 25 mg Tablet Taken Three Times Daily in Subjects With Acute Joint Pain

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ClinicalTrials.gov Identifier: NCT01666197
Recruitment Status : Completed
First Posted : August 16, 2012
Results First Posted : March 27, 2014
Last Update Posted : April 17, 2014
Sponsor:
Information provided by (Responsible Party):
Novartis

Study Description
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Brief Summary:
The purpose of this study is to evaluate the efficacy of diclofenac potassium 25 mg tablet compared with placebo taken three times a day in subjects with acute ankle sprains under 'in-use' conditions, in particular with regard to pain relief.

Condition or disease Intervention/treatment Phase
Ankle Sprain Drug: diclofenac potassium 25 mg tablet Drug: placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Multi-center, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Diclofenac Potassium 25 mg Tablet Taken Three Times Daily in Subjects With Acute Joint Pain
Study Start Date : August 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium

Arms and Interventions
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Arm Intervention/treatment
Experimental: diclofenac potassium 25 mg tablet Drug: diclofenac potassium 25 mg tablet
diclofenac potassium 25 mg tablet
Placebo Comparator: placebo Drug: placebo
placebo


Outcome Measures
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Primary Outcome Measures :
  1. Pain on Movement [ Time Frame: 48 hours ]
    Change on a Visual analog scale from Baseline. Pain on Movement at 48 hours assessed on a 100 mm visual analog scale with anchors at 0="No pain" and 100= "Extreme pain"


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female aged 18 years and over.
  • Acute sprain of the lateral ankle, Grade I-II, meeting baseline pain intensity level.
  • Injury within past 12 hours.

Exclusion Criteria:

  • Pain medication was taken within the 6 hours that precede randomization.
  • During the past 3 months: Grade I-III sprain of the same ankle.
  • During the past 6 months: Grade II-III sprain, any other significant injury (such as fracture or torn ligament), or surgery (except for skin or nails) of the same ankle or foot.
  • Pain or instability in the same ankle attributable to previous ankle sprain or any other trauma.
  • Ankle sprain attributable to a known disease affecting the ligaments, such as ligament hyperlaxity due to connective tissue disease (e.g., Marfan's syndrome, Down's syndrome, Ehlers-Danlos syndrome).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01666197


Locations
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Germany
Investigator
Brühl, Germany
Investigator
Essen, Germany
Investigator
Gilching, Germany
Investigator
Köln, Germany
Sponsors and Collaborators
Novartis
More Information
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Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01666197    
Other Study ID Numbers: 853-P-401
First Posted: August 16, 2012    Key Record Dates
Results First Posted: March 27, 2014
Last Update Posted: April 17, 2014
Last Verified: March 2014
Keywords provided by Novartis:
Acute Joint Pain
Additional relevant MeSH terms:
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Arthralgia
Ankle Injuries
Leg Injuries
Wounds and Injuries
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
 Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action