Diclofenac potassium liquid-filled soft gelatin capsules for the treatment of postbunionectomy pain.

06:00 EDT 1st September 2010 | BioPortfolio

Summary of "Diclofenac potassium liquid-filled soft gelatin capsules for the treatment of postbunionectomy pain."

Abstract Objective: Diclofenac potassium liquid-filled soft gelatin capsule (DPSGC) is a rapidly absorbed formulation of diclofenac approved for the treatment of mild to moderate acute pain in adults (>/=18 years of age). The objective of this study was to investigate the efficacy and safety of DPSGC 25 mg in a multicenter, randomized, double-blind, placebo-controlled study in patients experiencing pain following first metatarsal bunionectomy. Research design and methods: Patients experiencing a requisite level of pain (>/=4 based on an 11-point numeric pain rating scale [NPRS]; 0 = no pain, 10 = worst pain possible) on the day following surgery were randomized to receive DPSGC 25 mg or placebo. Patients received a second dose (remedication) on request or at 8 hours postdose followed by additional doses every 6 hours through the end of postsurgery Day 4. Rescue medication (hydrocodone/acetaminophen) was available as needed after the second dose. Clinical trial registration: NCT00375934. Main outcome measure: The primary efficacy endpoint was the average NPRS score over the 48 hour inpatient multiple-dose period. Results: DPSGC provided a significant improvement in mean 48 hour NPRS scores over placebo (3.29 vs 5.74, respectively; p < 0.0001), as well as for summed pain intensity difference (203.1 vs 86.6; p < 0.0001). Patients treated with DPSGC experienced a faster onset of meaningful pain relief compared with placebo (p = 0.0034). Rescue medication use on Day 1 and Day 2 was reduced in the DPSGC group compared with placebo (53.5% vs 92.1% on Day 1; 30.3% vs 67.3% on Day 2; p < 0.0001). DPSGC was well tolerated and no patients treated with DPSGC reported serious adverse events. As with any study, there are potential limitations including study design and patient population. Conclusion: These results indicate that DPSGC reduced pain in patients who underwent bunionectomy and this novel formulation of diclofenac potassium may be a practical option for treating mild to moderate acute pain.


Premier Research Group, Ltd, Austin, TX, USA.

Journal Details

This article was published in the following journal.

Name: Current medical research and opinion
ISSN: 1473-4877


DeepDyve research library

PubMed Articles [23950 Associated PubMed Articles listed on BioPortfolio]

Esterification of Ibuprofen in Soft Gelatin Capsules Formulations-Identification, Synthesis and Liquid Chromatography Separation of the Degradation Products.

Unknown impurities were identified in ibuprofen (IBU) soft gelatin capsules (SGCs) during long-term stability testing by a UHPLC method with UV detection and its chemical formula was determined using ...

Automated alkaline-induced salting-out homogeneous liquid-liquid extraction coupled with in-line organic-phase detection by an optical probe for the determination of diclofenac.

A fully automated alkaline-induced salting-out homogeneous liquid-liquid extraction (AI-SHLLE) procedure coupled with in-line organic-phase detection by an optical probe has been suggested. Diclofenac...

Cavity shape transformation during peeling on elastic microchannel-patterned substrates filled with a viscous liquid.

Inspired by the detachment mechanics of natural adhesive pads, we studied the change in cavity shape during peel tests on a 10% cross-linked polydimethylsiloxane (PDMS) elastic microchannel filled wit...

Cooperative Noncovalent Interactions Induce Ion Pair Separation in Diphenylsilanides.

This crystallographic and computational study describes an unusual potassium silanide structure. A contact ion pair is expected in the solid state between potassium and silicon, yet the potassium cati...

Mussels as bioindicators of diclofenac contamination in coastal environments.

Diclofenac a nonsteroidal anti-inflammatory drug (NSAID) has been confirmed as an emerging contaminant in the aquatic environment. Toxicology studies have revealed that harmful effects may emerge from...

Clinical Trials [2937 Associated Clinical Trials listed on BioPortfolio]

A Study to Assess the Efficacy and Tolerability of Diclofenac Potassium Soft Gelatin Capsules Compared With Ibuprofen Tablets in Patients With Moderate to Severe Postoperative Dental Pain

The study is designed to assess the efficacy and tolerability of diclofenac potassium soft gelatin capsules compared with ibuprofen tablets in patients with moderate to severe postoperativ...

Study to Compare the Pharmacokinetics of IV Diclofenac Sodium (2 Doses)Versus Oral Diclofenac Potassium

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...

The Safety and Effectiveness of Saquinavir Soft Gelatin Capsules Combined With Other Anti-HIV Drugs

To evaluate the safety and antiretroviral activity of saquinavir soft gelatin capsule formulation (SQV-SGC) in combination with other antiretroviral drugs.

The Anti-HIV Effects of Saquinavir Soft Gelatin Capsules Versus Indinavir in Patients Who Have Used Saquinavir Hard Gelatin Capsules for One Year

To determine, in HIV-infected patients, whether switching to a new soft gelatin capsule formulation of saquinavir or to indinavir following prolonged use of the original hard capsule formu...

Diclofenac Potassium on IANB Efficacy in Symptomatic Irreversible Pulpitis

The aim of this clinical trial is to evaluate the effect of pre-operative administration of diclofenac potassium on the efficacy of inferior alveolar nerve block on using 2% mepivacaine an...

Medical and Biotech [MESH] Definitions

An envelope of loose gel surrounding a bacterial cell which is associated with the virulence of pathogenic bacteria. Some capsules have a well-defined border, whereas others form a slime layer that trails off into the medium. Most capsules consist of relatively simple polysaccharides but there are some bacteria whose capsules are made of polypeptides.

A product formed from skin, white connective tissue, or bone COLLAGEN. It is used as a protein food adjuvant, plasma substitute, hemostatic, suspending agent in pharmaceutical preparations, and in the manufacturing of capsules and suppositories.

Hard or soft soluble containers used for the oral administration of medicine.

Any liquid or solid preparation made specifically for the growth, storage, or transport of microorganisms or other types of cells. The variety of media that exist allow for the culturing of specific microorganisms and cell types, such as differential media, selective media, test media, and defined media. Solid media consist of liquid media that have been solidified with an agent such as AGAR or GELATIN.

The removal of a soluble component from a liquid mixture by contact with a second liquid, immiscible with the carrier liquid, in which the component is preferentially soluble. (McGraw-Hill Dictionary of Scientific and Technical Terms, 6th ed)

Quick Search

DeepDyve research library

Relevant Topics

An anesthesiologist (US English) or anaesthetist (British English) is a physician trained in anesthesia and perioperative medicine. Anesthesiologists are physicians who provide medical care to patients in a wide variety of (usually acute) situations. ...

Pain is defined by the International Association for the Study of Pain as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage”. Some illnesses can be excruci...

Searches Linking to this Article