Diclofenac Delayed Release (Diclofenac Sodium) - Summary

SUMMARY

Diclofenac sodium is a benzeneacetic acid derivative, designated chemically as 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt.

Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

Diclofenac sodium delayed-release tablets, are indicated:

• For relief of signs and symptoms of osteoarthritis
• For relief of signs and symptoms of rheumatoid arthritis
• For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis

NEWS HIGHLIGHTS

Published Studies Related to Diclofenac Delayed Release (Diclofenac)

Diclofenac sodium gel in patients with primary hand osteoarthritis: a randomized, double-blind, placebo-controlled trial. [2009.09]
OBJECTIVE: To measure the efficacy and safety of diclofenac sodium gel in patients with primary hand osteoarthritis (OA)... CONCLUSION: Topical diclofenac sodium gel was generally well tolerated and effective in primary hand OA. (NCT ID: NCT00171665).

Diclofenac potassium restores objective and subjective measures of sleep quality in women with primary dysmenorrhea. [2009.08.01]
STUDY OBJECTIVES: Primary dysmenorrhea is a common gynecological disorder that disrupts daytime functioning and nighttime sleep quality. We determined the effectiveness of diclofenac potassium, compared to placebo, in alleviating nighttime pain and restoring sleep architecture in women with primary dysmenorrhea... CONCLUSION: Diclofenac potassium effectively attenuates nighttime dysmenorrheic pain and restores subjective and objective measures of sleep quality to values recorded in a pain-free phase of the menstrual cycle.

Pupil size with and without adrenaline with diclofenac use before cataract surgery. [2009.08]
PURPOSE: To determine whether adrenaline in the irrigating solution is necessary when diclofenac eyedrops are used before cataract surgery. SETTING: Pasqua Hospital, Regina, Saskatchewan, Canada... CONCLUSIONS: When diclofenac eyedrops were used before cataract surgery, the smaller preoperative pupils constricted significantly less when adrenaline was added to the irrigating solution. This was not true for larger pupils. Thus, adrenaline in the irrigating solution does not appear necessary in eyes with large preoperative pupils.

Intramuscular diclofenac for analgesia after cesarean delivery: a randomized controlled trial. [2009.06]
OBJECTIVE: To evaluate the effectiveness of intramuscular diclofenac in postoperative cesarean section pain control... CONCLUSION: Diclofenac can be used safely to reduce the requirement of rescue drugs for pain control in postoperative cesarean section.

Baseline factors associated with congestive heart failure in patients receiving etoricoxib or diclofenac: multivariate analysis of the MEDAL program. [2009.06]
CONCLUSION: History of CHF was highly associated with risk for CHF hospitalization. Hypertension, diabetes, and older age also increased risk modestly. There appeared to be a dose-related increase in CHF with etoricoxib compared with diclofenac, which reached statistical significance when the etoricoxib 90 mg groups (osteoarthritis and rheumatoid arthritis) were pooled.

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Clinical Trials Related to Diclofenac Delayed Release (Diclofenac)

Study to Compare the Pharmacokinetics of IV Diclofenac Sodium (2 Doses)Versus Oral Diclofenac Potassium [Completed]
The purpose of this study is to assess the pharmacokinetic parameters of intravenous diclofenac sodium (DIC075V) 18. 75 mg and 37. 5 mg following single- and multiple-dose administration, as compared to oral diclofenac potassium (Cataflam® 50 mg), the approved reference product.

Assess Platelet Function and Safety After Administration of Injectable Diclofenac Compared to Ketorolac and Aspirin in Adult Male Volunteers [Completed]
This study will assess platelet function and safety in healthy male volunteers following doses of intravenous diclofenac compared to cataflam, intravenous ketorolac and aspirin.

Diclofenac Patch for Treatment of Mild to Moderate Ankle Sprain [Active, not recruiting]
The primary purpose of this study is to assess the effectiveness of once daily application of a diclofenac sodium patch to the skin near or over the painful area. In this study, the location being studied will be either the left or right ankle.

The secondary purpose of this study is to assess the safety and tolerability of a diclofenac patch on the skin.

Diclofenac Patch for Treatment of Mild to Moderate Tendonitis or Bursitis [Completed]
The primary purpose of this study is to assess the effectiveness of once daily application of a diclofenac sodium patch to the skin near or over the painful area. In this study, the location being studied will be one of the following: the affected shoulder, elbow, or wrist.

The secondary purpose of this study is to assess the safety and tolerability of the diclofenac patch on the subject's skin, in the location being studied.

Efficacy and Safety of Diclofenac Sodium Gel (DSG) in Knee Osteoarthritis [Completed]
This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of knee osteoarthritis.

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