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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01226095
• Other study ID #: P12-162
• Status: Completed
• Phase: N/A
• First received: September 7, 2010
• Last updated: September 16, 2013
• Start date: June 2010
• Est. completion date: November 2010

Study information

• Verified date: January 2012
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 519
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Morning Stiffness
• Osteoarthritis
• Pain

Locations

Country	Name	City	State
Egypt	Site Reference ID/Investigator# 42584	Alexandria
Egypt	Site Reference ID/Investigator# 42585	Alexandria
Egypt	Site Reference ID/Investigator# 42591	Alexandria
Egypt	Site Reference ID/Investigator# 42593	Alexandria
Egypt	Site Reference ID/Investigator# 42594	Alexandria
Egypt	Site Reference ID/Investigator# 29755	Cairo
Egypt	Site Reference ID/Investigator# 42582	Cairo
Egypt	Site Reference ID/Investigator# 42583	Cairo
Egypt	Site Reference ID/Investigator# 42586	Cairo
Egypt	Site Reference ID/Investigator# 42587	Cairo
Egypt	Site Reference ID/Investigator# 42588	Cairo
Egypt	Site Reference ID/Investigator# 42589	Cairo
Egypt	Site Reference ID/Investigator# 42590	Cairo
Egypt	Site Reference ID/Investigator# 42592	Cairo
Egypt	Site Reference ID/Investigator# 42595	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Abbott	Clintek

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	No
Primary	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).	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	No
Secondary	Percent of Participant Compliance	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	No
Secondary	Number of Participants With Joint Tenderness/Stiffness at Each Visit	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	No
Secondary	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).	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	No
Secondary	Duration of Morning Stiffness	The duration of morning stiffness in minutes was assessed at each visit.	Baseline, 2 weeks, and 4 weeks	No
Secondary	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)	The number of participants who achieved an 80% reduction from baseline in morning stiffness was calculated at each visit.	2 and 4 weeks	No
Secondary	Number of Participants With the Ability to Carry Out Normal Activities at Each Visit	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	No
Secondary	Number of Participants Who Experienced Adverse Events and Serious Adverse Events	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	Yes