Clinical trial NCT01226095: Evaluation of the Effectiveness, Compliance of Ibuprofen in a Sustained Release Form in the Treatment of Egyptian Osteoarthritic Patients
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Pain
Morning Stiffness
Keywords: Osteoarthritis
Pain
Morning stiffness
Lead sponsor: Abbott
Sponsor class: INDUSTRY
Collaborators: name: Clintek
First posted: 2010-10-21
Enrollment: 519
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinics

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Baseline and 4 weeks
measure: 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).
timeFrame: 4 weeks
Secondary outcomes:
measure: Percent of Participant Compliance
timeFrame: 2 and 4 weeks
measure: Number of Participants With Joint Tenderness/Stiffness at Each Visit
timeFrame: Baseline, 2 weeks, and 4 weeks
measure: 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).
timeFrame: 2 and 4 weeks
measure: Duration of Morning Stiffness
timeFrame: Baseline, 2 weeks, and 4 weeks
measure: 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)
timeFrame: 2 and 4 weeks
measure: Number of Participants With the Ability to Carry Out Normal Activities at Each Visit
timeFrame: Baseline, 2 weeks, and 4 weeks
measure: Number of Participants Who Experienced Adverse Events and Serious Adverse Events
timeFrame: Baseline to 4 weeks
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Site Reference ID/Investigator# 42584
city: Alexandria
country: Egypt
facility: Site Reference ID/Investigator# 42585
city: Alexandria
country: Egypt
facility: Site Reference ID/Investigator# 42591
city: Alexandria
country: Egypt
facility: Site Reference ID/Investigator# 42593
city: Alexandria
country: Egypt
facility: Site Reference ID/Investigator# 42594
city: Cairo
country: Egypt
facility: Site Reference ID/Investigator# 29755
city: Cairo
country: Egypt
facility: Site Reference ID/Investigator# 42582
city: Cairo
country: Egypt
facility: Site Reference ID/Investigator# 42583
city: Cairo
country: Egypt
facility: Site Reference ID/Investigator# 42586
city: Cairo
country: Egypt
facility: Site Reference ID/Investigator# 42587
city: Cairo
country: Egypt
facility: Site Reference ID/Investigator# 42588
city: Cairo
country: Egypt
facility: Site Reference ID/Investigator# 42589
city: Cairo
country: Egypt
facility: Site Reference ID/Investigator# 42590
city: Cairo
country: Egypt
facility: Site Reference ID/Investigator# 42592
city: Cairo
country: Egypt
facility: Site Reference ID/Investigator# 42595
Study officials:
affiliation: Abbott (Egypt)
name: Rasha Eldessouky, MBBC
role: STUDY_DIRECTOR
References: