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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01666197
First Posted: August 16, 2012
Last Update Posted: April 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis
  Purpose
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 Intervention Phase
Ankle Sprain Drug: diclofenac potassium 25 mg tablet Drug: placebo Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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"


Enrollment: 100
Study Start Date: August 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: diclofenac potassium 25 mg tablet Drug: diclofenac potassium 25 mg tablet
diclofenac potassium 25 mg tablet
Placebo Comparator: placebo Drug: placebo
placebo

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
Germany
Investigator
Brühl, Germany
Investigator
Essen, Germany
Investigator
Gilching, Germany
Investigator
Köln, Germany
Sponsors and Collaborators
Novartis
  More Information

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01666197     History of Changes
Other Study ID Numbers: 853-P-401
First Submitted: August 14, 2012
First Posted: August 16, 2012
Results First Submitted: February 12, 2014
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:
Ankle Injuries
Arthralgia
Leg Injuries
Wounds and Injuries
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
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