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

An observational study of Osteoarthritis and Pain, run by Abbott at 15 sites in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Osteoarthritis, Pain, Morning Stiffness
How many people: 519 participants
Where: 15 sitesEgypt
Study dates: Jun 2010to Nov 2010
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Primary care clinics

Who may be able to join

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

Who cannot join

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

Show all 10Show fewer

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

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

Egypt15 sites

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

Other trials in Egypt

About this study

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

Read the 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.

Conditions: Osteoarthritis, Pain, Morning Stiffness
Keywords: Osteoarthritis, Pain, Morning stiffness
Medical subject headings: Osteoarthritis, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01226095
Study group	Role	What they receive
Osteoarthritic patients		Patients male or female, age ≥ 18 having clinical or radiological evidence of osteoarthritis

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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).
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.
Measured: 4 weeks

Secondary outcomes (7)

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).
Measured: 2 and 4 weeks
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.
Measured: 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).
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.
Measured: 2 and 4 weeks
Duration of Morning Stiffness
The duration of morning stiffness in minutes was assessed at each visit.
Measured: 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)
The number of participants who achieved an 80% reduction from baseline in morning stiffness was calculated at each visit.
Measured: 2 and 4 weeks
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.
Measured: Baseline, 2 weeks, and 4 weeks
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.
Measured: Baseline to 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2010Nov 2010

First posted21 Oct 2010 (estimated)
Study startJun 2010
Primary completionNov 2010
Study completionNov 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for OsteoarthritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Time perspective: Prospective
Enrolment: 519 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01226095
Sponsor's protocol ID: P12-162
Status last verified: Jan 2012
First submitted: 7 Sep 2010
Last updated: 20 Sep 2013
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01226095
Acronym / sponsor ID: P12-162
Conditions: Osteoarthritis, Pain, Morning Stiffness
Keywords: Osteoarthritis, Pain, Morning stiffness
Study type: Observational
Recruitment status: Completed
Enrolment: 519 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Collaborators: Clintek
Study start: Jun 2010
Primary completion: Nov 2010 (actual)
Study completion: Nov 2010 (actual)
First posted: 21 Oct 2010 (estimated)
Results: Posted 23 Jan 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Osteoarthritic patients	–	–Patients male or female, age ≥ 18 having clinical or radiological evidence of osteoarthritis

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Primary care clinics

Key inclusion criteria (5 listed)

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

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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.
Time frame: 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.
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).
Time frame: 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.

7 secondary outcomes

Percent of Participant Compliance
Time frame: 2 and 4 weeks
Number of Participants With Joint Tenderness/Stiffness at Each Visit
Time frame: 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).
Time frame: 2 and 4 weeks
Duration of Morning Stiffness
Time frame: 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)
Time frame: 2 and 4 weeks
Number of Participants With the Ability to Carry Out Normal Activities at Each Visit
Time frame: Baseline, 2 weeks, and 4 weeks
Number of Participants Who Experienced Adverse Events and Serious Adverse Events
Time frame: Baseline to 4 weeks

Results and safety

Results posted to the registry on 23 Jan 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Brufen Retard	519	518

Primary outcome: 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.

Time frame: Baseline and 4 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Brufen Retard Baseline (Visit 1) n = 519	Brufen Retard (Visit 3, Week 4) n = 519
Value	6.12 (1.38)	2.10 (1.70)

Brufen Retard Baseline (Visit 1) vs Brufen Retard (Visit 3, Week 4): p <0.0001, t-test, 2 sided

Population analysed: Effectiveness data were analyzed using the intent-to-treat (ITT) and per-protocol (PP) populations, each of which consisted of all 519 enrolled participants.

Primary outcome: 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).

Time frame: 4 weeks. Number. Unit: Participants

Measure	Brufen Retard (Visit 3, Week 4) n = 519
Improved	516
No change	3
Worsened	0

Population analysed: Effectiveness data were analyzed using the intent-to-treat (ITT) and per-protocol (PP) populations, each of which consisted of all 519 enrolled participants.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: All adverse events that occurred during the course of the study were reported. Adverse events occurring during the study were reported up to 30 days after the last dose of open-label ibuprofen sustained release form.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Brufen Retard	0 of 519 (0%)	41 of 519 (7.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rasha Eldessouky, MBBC study director

Abbott (Egypt)

15 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Osteoarthritis and Pain, run by Abbott at 15 sites in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: Baseline and 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01226095.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2013.