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

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: August 14, 2012
Last updated: March 31, 2014
Last verified: March 2014

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01666197

Brühl, Germany
Essen, Germany
Gilching, Germany
Köln, Germany
Sponsors and Collaborators
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01666197     History of Changes
Other Study ID Numbers: 853-P-401
Study First Received: August 14, 2012
Results First Received: February 12, 2014
Last Updated: March 31, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices (BfArM)

Keywords provided by Novartis:
Acute Joint Pain

Additional relevant MeSH terms:
Sprains and Strains
Ankle Injuries
Joint Diseases
Musculoskeletal Diseases
Signs and Symptoms
Wounds and Injuries
Leg Injuries
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 23, 2014