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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... Full description

Journal Title: Current medical research and opinion 2010-10, Vol.26 (10), p.2375-2384
Main Author: Daniels, Stephen E
Other Authors: Baum, Douglas R , Clark, Francis , Golf, Michael H , McDonnell, Mark E , Boesing, Stephen E
Format: Electronic Article Electronic Article
Language: English
Subjects:
Quelle: Alma/SFX Local Collection
Publisher: England: Informa UK Ltd
ID: ISSN: 0300-7995
Link: https://www.ncbi.nlm.nih.gov/pubmed/20804444
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recordid: cdi_pubmed_primary_20804444
title: Diclofenac potassium liquid-filled soft gelatin capsules for the treatment of postbunionectomy pain
format: Article
creator:
  • Daniels, Stephen E
  • Baum, Douglas R
  • Clark, Francis
  • Golf, Michael H
  • McDonnell, Mark E
  • Boesing, Stephen E
subjects:
  • Adolescent
  • Adult
  • Aged
  • Anti-Inflammatory Agents, Non-Steroidal - administration & dosage
  • Anti-Inflammatory Agents, Non-Steroidal - adverse effects
  • Bunionectomy
  • Capsules
  • Diclofenac - administration & dosage
  • Diclofenac - adverse effects
  • Diclofenac potassium
  • Dispersion technology
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Female
  • Gelatin
  • Hallux Valgus - drug therapy
  • Hallux Valgus - surgery
  • Humans
  • Male
  • Metatarsal Bones - surgery
  • Middle Aged
  • Orthopedics - methods
  • Pain relief
  • Pain, Postoperative - drug therapy
  • Placebos
  • Young Adult
ispartof: Current medical research and opinion, 2010-10, Vol.26 (10), p.2375-2384
description: 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 
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 0300-7995
fulltext: fulltext
issn:
  • 0300-7995
  • 1473-4877
url: Link


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titleDiclofenac potassium liquid-filled soft gelatin capsules for the treatment of postbunionectomy pain
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descriptionAbstract 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.
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subjectAdolescent ; Adult ; Aged ; Anti-Inflammatory Agents, Non-Steroidal - administration & dosage ; Anti-Inflammatory Agents, Non-Steroidal - adverse effects ; Bunionectomy ; Capsules ; Diclofenac - administration & dosage ; Diclofenac - adverse effects ; Diclofenac potassium ; Dispersion technology ; Dose-Response Relationship, Drug ; Double-Blind Method ; Female ; Gelatin ; Hallux Valgus - drug therapy ; Hallux Valgus - surgery ; Humans ; Male ; Metatarsal Bones - surgery ; Middle Aged ; Orthopedics - methods ; Pain relief ; Pain, Postoperative - drug therapy ; Placebos ; Young Adult
ispartofCurrent medical research and opinion, 2010-10, Vol.26 (10), p.2375-2384
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descriptionAbstract 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.
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4Anti-Inflammatory Agents, Non-Steroidal - adverse effects
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19Metatarsal Bones - surgery
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abstractAbstract 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.
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pmid20804444
doi10.1185/03007995.2010.515478