Document Detail

Double-blind, randomized, controlled study on the efficacy and safety of a novel diclofenac epolamine gel formulated with lecithin for the treatment of sprains, strains and contusions.
MedLine Citation:
PMID:  12866363     Owner:  NLM     Status:  MEDLINE    
To evaluate the efficacy of the new diclofenac-N-(2-hydroxyethyl)-pyrrolidine gel formulated with lecithin (DHEP lecithin) compared with diclofenac-N-(2-hydroxyethyl)-pyrrolidine gel (DHEP gel) without lecithin in mild-to-moderate posttraumatic injuries (grade 1 ankle, knee and muscle injuries), a multicenter, double-blind, controlled study was carried out. A total of 100 patients were enrolled and randomly assigned to either DHEP lecithin (n = 52) or DHEP gel (n = 48) treatment. All patients concluded the treatment period except for five, who did not turn up to their respective investigational sites for the follow-up visits. According to an intention-to-treat approach, they were all included in the statistical analysis. As for the efficacy and safety analysis, the primary variable was "pain on movement" as measured by a Huskisson visual analog scale. During the first 3 days of treatment each group recorded a significant within-group decrease, but patients treated with DHEP lecithin showed a decrease in absolute value that was statistically greater than that obtained with DHEP gel (p = 0.025). At the end of the treatment period (day 10) the difference between groups was still statistically significant (p = 0.036). The statistical analysis of the secondary efficacy variables showed significant results in favor of DHEP lecithin treatment. These were superimposable on the results found for the primary variable. The global efficacy and tolerability judgments, reported either by patient or by physician, showed no statistical difference between treatment groups. Due to the presence of lecithin in the new gel formulation, DHEP lecithin showed a faster and significantly more marked therapeutic effect compared with that of DHEP gel.
P Mahler; F Mahler; H Duruz; M Ramazzina; V Liguori; G Mautone
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial    
Journal Detail:
Title:  Drugs under experimental and clinical research     Volume:  29     ISSN:  0378-6501     ISO Abbreviation:  Drugs Exp Clin Res     Publication Date:  2003  
Date Detail:
Created Date:  2003-07-17     Completed Date:  2003-10-14     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  7802135     Medline TA:  Drugs Exp Clin Res     Country:  Switzerland    
Other Details:
Languages:  eng     Pagination:  45-52     Citation Subset:  IM    
Hôpital de la Tour, Sports Medicine Center and Casualties, Meyrin, Switzerland.
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MeSH Terms
Acetaminophen / therapeutic use
Administration, Topical
Analgesics, Non-Narcotic / therapeutic use
Ankle Injuries / drug therapy
Anti-Inflammatory Agents / chemistry,  therapeutic use*
Contusions / drug therapy*
Diclofenac / analogs & derivatives*,  chemistry,  therapeutic use*
Double-Blind Method
Knee Injuries / drug therapy
Leg Injuries / drug therapy*
Middle Aged
Pain Measurement
Phosphatidylcholines / chemistry*
Prospective Studies
Sprains and Strains / drug therapy*
Reg. No./Substance:
0/Analgesics, Non-Narcotic; 0/Anti-Inflammatory Agents; 0/Gels; 0/Phosphatidylcholines; 103-90-2/Acetaminophen; 119623-66-4/diclofenac hydroxyethylpyrrolidine; 15307-86-5/Diclofenac

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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