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Evaluation of the Effectiveness, Compliance of Ibuprofen in a Sustained Release Form in the Treatment of Egyptian Osteoarthritic Patients

16 settembre 2013 aggiornato da: Abbott

A Prospective, Multi-center, Post-marketing Observational Study to Evaluate the Effectiveness and Compliance of Ibuprofen in a Sustained Release Form in the Treatment of Egyptian Osteoarthritic Patients

This is a prospective, multi-center, post-marketing observational study to evaluate the effectiveness and compliance of ibuprofen in a sustained release form in the treatment of Egyptian osteoarthritic patients.

Panoramica dello studio

Stato

Completato

Condizioni

Descrizione dettagliata

This was a prospective, longitudinal, multicenter observational study conducted in a clinical practice setting where the study product was used in osteoarthritis patients as indicated in the approved package insert; the dosing regimen of Brufen retard is 2 tablets as a single dose once daily.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

519

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Egitto
      • Alexandria, Egitto
        • Site Reference ID/Investigator# 42584
      • Alexandria, Egitto
        • Site Reference ID/Investigator# 42585
      • Alexandria, Egitto
        • Site Reference ID/Investigator# 42591
      • Alexandria, Egitto
        • Site Reference ID/Investigator# 42593
      • Alexandria, Egitto
        • Site Reference ID/Investigator# 42594
      • Cairo, Egitto
        • Site Reference ID/Investigator# 29755
      • Cairo, Egitto
        • Site Reference ID/Investigator# 42582
      • Cairo, Egitto
        • Site Reference ID/Investigator# 42583
      • Cairo, Egitto
        • Site Reference ID/Investigator# 42586
      • Cairo, Egitto
        • Site Reference ID/Investigator# 42587
      • Cairo, Egitto
        • Site Reference ID/Investigator# 42588
      • Cairo, Egitto
        • Site Reference ID/Investigator# 42589
      • Cairo, Egitto
        • Site Reference ID/Investigator# 42590
      • Cairo, Egitto
        • Site Reference ID/Investigator# 42592
      • Cairo, Egitto
        • Site Reference ID/Investigator# 42595

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Primary care clinics

Descrizione

Inclusion Criteria:

  • Patients seeking treatment for osteoarthritis and there are clinical or radiological evidence of the disease,
  • Male or female, age ≥ 18
  • Designated to treatment with Ibuprofen in a sustained release form (Brufen Retard) according to the best criterion of the physician and if he decides to treat the patient according to labeled indication and dose for 4 weeks.
  • Patients who have given their written informed consent to participate in the study
  • Patients who are currently taking non steroidal anti inflammatory drugs (NSAIDs), should complete an initial washout phase 10 days depending on the half life of the drug taken

Exclusion Criteria:

  • Contraindications as described in company core data sheet (CCDS) and specifically
  • Patients with active peptic ulcer
  • Patients who have presented reactions of hypersensitivity (asthma , rhinitis or urticaria ) with ibuprofen or other anti-inflammatory non steroids
  • Patients with active cardiovascular disease and those taking aspirin/warfarin for prophylaxis for myocardial infarction (MI) or stroke
  • Patients with moderate to severe renal diseases
  • Patients with moderate to severe hepatic disease
  • Patients with Crohn's disease
  • Patients included currently in another study
  • Women of childbearing potential must not be pregnant
  • Any patients the investigators consider ineligible for this study

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Osteoarthritic patients
Patients male or female, age ≥ 18 having clinical or radiological evidence of osteoarthritis

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Day and Night Mean Pain Score for the Previous 24 Hours on a Nine-point Scale (0 = no Pain to 8 = Very Severe Pain) at Visit 3 (4 Weeks Following Treatment) in Comparison to Baseline.
Lasso di tempo: Baseline and 4 weeks
Scoring of day and night pain for the previous 24 hours was performed on a nine-point scale (0 = no pain to 8 = very severe pain) at each visit and compared to baseline. The overall mean pain score was calculated for participants who completed the study at each visit.
Baseline and 4 weeks
Number of Participants Who Improved (Reduced Pain), Had no Change (Equal Scores at Baseline and Visit), and Worsened (Increased Pain) at Visit 3 (After 4 Weeks of Treatment).
Lasso di tempo: 4 weeks
Scoring of day and night pain for the previous 24 hours was performed on a 9-point scale (0 = no pain to 8 = very severe pain) at each visit. The number of participants at Visit 3 (after 4 weeks of treatment) who improved (had reduced pain; from higher baseline score to lower Visit 3 score), had no change (equal scores at baseline and Visit 3), and worsened (increased pain; from lower baseline score to higher Visit 3 score) was calculated.
4 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percent of Participant Compliance
Lasso di tempo: 2 and 4 weeks
The frequency with which the participant forgot to take treatment or changed dose/administration was determined by comparing the actual number of tablets taken by the participant to the scheduled number of tablets since the last visit. Results are presented in percent (0 - 100% scale, with 100% being perfect compliance and 0% being no compliance at all).
2 and 4 weeks
Number of Participants With Joint Tenderness/Stiffness at Each Visit
Lasso di tempo: Baseline, 2 weeks, and 4 weeks
Joint tenderness/stiffness was measured using a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) at each visit.
Baseline, 2 weeks, and 4 weeks
Number of Participants Who Improved (Reduced), Had no Change (Equal at Baseline and Visit), and Worsened (Increased) in Joint Tenderness/Stiffness at Visit 2 (After 2 Weeks of Treatment) and Visit 3 (After 4 Weeks of Treatment).
Lasso di tempo: 2 and 4 weeks
Duration of morning stiffness at each visit was assessed and the number of participants who improved, had no change, or worsened at each visit, following 2 and 4 weeks of treatment (Visit 2 and Visit 3, respectively) was calculated.
2 and 4 weeks
Duration of Morning Stiffness
Lasso di tempo: Baseline, 2 weeks, and 4 weeks
The duration of morning stiffness in minutes was assessed at each visit.
Baseline, 2 weeks, and 4 weeks
Number of Participants With 80% Reduction From Baseline in Duration of Morning Stiffness at Visit 2 (2 Weeks of Treatment) and Visit 3 (4 Weeks of Treatment)
Lasso di tempo: 2 and 4 weeks
The number of participants who achieved an 80% reduction from baseline in morning stiffness was calculated at each visit.
2 and 4 weeks
Number of Participants With the Ability to Carry Out Normal Activities at Each Visit
Lasso di tempo: Baseline, 2 weeks, and 4 weeks
The number of participants who were able or unable to carry out normal activities was assessed at each visit.
Baseline, 2 weeks, and 4 weeks
Number of Participants Who Experienced Adverse Events and Serious Adverse Events
Lasso di tempo: Baseline to 4 weeks
Tolerability was assessed by collecting adverse events during the course of the study up to 30 days following the last dose of Brufen Retard. The number of participants experiencing a serious or non-serious adverse event is summarized. See the Reported Adverse Event section for details.
Baseline to 4 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Abbott

Collaboratori

Clintek

Investigatori

  • Direttore dello studio: Rasha Eldessouky, MBBC, Abbott (Egypt)

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 giugno 2010

Completamento primario (Effettivo)

1 novembre 2010

Completamento dello studio (Effettivo)

1 novembre 2010

Date di iscrizione allo studio

Primo inviato

7 settembre 2010

Primo inviato che soddisfa i criteri di controllo qualità

20 ottobre 2010

Primo Inserito (Stima)

21 ottobre 2010

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

20 settembre 2013

Ultimo aggiornamento inviato che soddisfa i criteri QC

16 settembre 2013

Ultimo verificato

1 gennaio 2012

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • P12-162

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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