- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01226095
Evaluation of the Effectiveness, Compliance of Ibuprofen in a Sustained Release Form in the Treatment of Egyptian Osteoarthritic Patients
16. september 2013 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Faktiske)
519
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Alexandria, Egypt
- Site Reference ID/Investigator# 42584
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Alexandria, Egypt
- Site Reference ID/Investigator# 42585
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Alexandria, Egypt
- Site Reference ID/Investigator# 42591
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Alexandria, Egypt
- Site Reference ID/Investigator# 42593
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Alexandria, Egypt
- Site Reference ID/Investigator# 42594
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Cairo, Egypt
- Site Reference ID/Investigator# 29755
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Cairo, Egypt
- Site Reference ID/Investigator# 42582
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Cairo, Egypt
- Site Reference ID/Investigator# 42583
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Cairo, Egypt
- Site Reference ID/Investigator# 42586
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Cairo, Egypt
- Site Reference ID/Investigator# 42587
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Cairo, Egypt
- Site Reference ID/Investigator# 42588
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Cairo, Egypt
- Site Reference ID/Investigator# 42589
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Cairo, Egypt
- Site Reference ID/Investigator# 42590
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Cairo, Egypt
- Site Reference ID/Investigator# 42592
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Cairo, Egypt
- Site Reference ID/Investigator# 42595
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Primary care clinics
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Osteoarthritic patients
Patients male or female, age ≥ 18 having clinical or radiological evidence of osteoarthritis
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
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.
Tidsramme: Baseline and 4 weeks
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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.
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Baseline and 4 weeks
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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).
Tidsramme: 4 weeks
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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.
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4 weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Percent of Participant Compliance
Tidsramme: 2 and 4 weeks
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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).
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2 and 4 weeks
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Number of Participants With Joint Tenderness/Stiffness at Each Visit
Tidsramme: Baseline, 2 weeks, and 4 weeks
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Joint tenderness/stiffness was measured using a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) at each visit.
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Baseline, 2 weeks, and 4 weeks
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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).
Tidsramme: 2 and 4 weeks
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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.
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2 and 4 weeks
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Duration of Morning Stiffness
Tidsramme: Baseline, 2 weeks, and 4 weeks
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The duration of morning stiffness in minutes was assessed at each visit.
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Baseline, 2 weeks, and 4 weeks
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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)
Tidsramme: 2 and 4 weeks
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The number of participants who achieved an 80% reduction from baseline in morning stiffness was calculated at each visit.
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2 and 4 weeks
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Number of Participants With the Ability to Carry Out Normal Activities at Each Visit
Tidsramme: Baseline, 2 weeks, and 4 weeks
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The number of participants who were able or unable to carry out normal activities was assessed at each visit.
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Baseline, 2 weeks, and 4 weeks
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Number of Participants Who Experienced Adverse Events and Serious Adverse Events
Tidsramme: Baseline to 4 weeks
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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.
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Baseline to 4 weeks
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juni 2010
Primær fullføring (Faktiske)
1. november 2010
Studiet fullført (Faktiske)
1. november 2010
Datoer for studieregistrering
Først innsendt
7. september 2010
Først innsendt som oppfylte QC-kriteriene
20. oktober 2010
Først lagt ut (Anslag)
21. oktober 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
20. september 2013
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. september 2013
Sist bekreftet
1. januar 2012
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- P12-162
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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