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NCT Number: NCT01226095

Evaluation of the Effectiveness, 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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Morning Stiffness Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Site Reference ID/Investigator# 42584, Alexandria, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Percent of Participant Compliance

    Time frame: 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. Number of Participants With Joint Tenderness/Stiffness at Each Visit

    Time frame: 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.

  3. 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 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.

  4. Duration of Morning Stiffness

    Time frame: Baseline, 2 weeks, and 4 weeks

    The duration of morning stiffness in minutes was assessed at each visit.

  5. 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

    The number of participants who achieved an 80% reduction from baseline in morning stiffness was calculated at each visit.

  6. Number of Participants With the Ability to Carry Out Normal Activities at Each Visit

    Time frame: 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.

  7. Number of Participants Who Experienced Adverse Events and Serious Adverse Events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Collaborators

  • Clintek

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Oct 21, 2010
Registry last updated
Sep 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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