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

16. September 2013 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

519

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Primary care clinics

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
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.
Zeitfenster: 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).
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percent of Participant Compliance
Zeitfenster: 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
Zeitfenster: 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).
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Abbott

Mitarbeiter

Clintek

Ermittler

  • Studienleiter: Rasha Eldessouky, MBBC, Abbott (Egypt)

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Juni 2010

Primärer Abschluss (Tatsächlich)

1. November 2010

Studienabschluss (Tatsächlich)

1. November 2010

Studienanmeldedaten

Zuerst eingereicht

7. September 2010

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

20. Oktober 2010

Zuerst gepostet (Schätzen)

21. Oktober 2010

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

20. September 2013

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

16. September 2013

Zuletzt verifiziert

1. Januar 2012

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • P12-162

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