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

Ankle Sprain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01666197
• Other study ID #: 853-P-401
• Status: Completed
• Phase: Phase 4
• First received: August 14, 2012
• Last updated: March 31, 2014
• Start date: August 2012
• Est. completion date: January 2013

Study information

• Verified date: March 2014
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices (BfArM)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankle Sprain
• Arthralgia

Intervention

Drug:
• diclofenac potassium 25 mg tablet
diclofenac potassium 25 mg tablet
• placebo
placebo

Locations

Country	Name	City	State
Germany	Investigator	Brühl
Germany	Investigator	Essen
Germany	Investigator	Gilching
Germany	Investigator	Köln

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain on Movement	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"	48 hours	No