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

This study has been completed.
Sponsor:
Collaborator:
Clintek
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01226095
First received: September 7, 2010
Last updated: September 16, 2013
Last verified: January 2012
  Purpose

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.


Condition
Osteoarthritis
Pain
Morning Stiffness

Study Type: Observational
Study Design: Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Percent of Participant Compliance [ Time Frame: 2 and 4 weeks ] [ Designated as safety issue: No ]
    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).

  • Number of Participants With Joint Tenderness/Stiffness at Each Visit [ Time Frame: Baseline, 2 weeks, and 4 weeks ] [ Designated as safety issue: No ]
    Joint tenderness/stiffness was measured using a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) at each visit.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Duration of Morning Stiffness [ Time Frame: Baseline, 2 weeks, and 4 weeks ] [ Designated as safety issue: No ]
    The duration of morning stiffness in minutes was assessed at each visit.

  • 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 ] [ Designated as safety issue: No ]
    The number of participants who achieved an 80% reduction from baseline in morning stiffness was calculated at each visit.

  • Number of Participants With the Ability to Carry Out Normal Activities at Each Visit [ Time Frame: Baseline, 2 weeks, and 4 weeks ] [ Designated as safety issue: No ]
    The number of participants who were able or unable to carry out normal activities was assessed at each visit.

  • Number of Participants Who Experienced Adverse Events and Serious Adverse Events [ Time Frame: Baseline to 4 weeks ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 519
Study Start Date: June 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Osteoarthritic patients
Patients male or female, age ≥ 18 having clinical or radiological evidence of osteoarthritis

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinics

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01226095

Locations
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# 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# 42583
Cairo, Egypt
Site Reference ID/Investigator# 42592
Cairo, Egypt
Site Reference ID/Investigator# 29755
Cairo, Egypt
Site Reference ID/Investigator# 42582
Cairo, Egypt
Site Reference ID/Investigator# 42595
Cairo, Egypt
Sponsors and Collaborators
Abbott
Clintek
Investigators
Study Director: Rasha Eldessouky, MBBC Abbott (Egypt)
  More Information

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01226095     History of Changes
Other Study ID Numbers: P12-162
Study First Received: September 7, 2010
Results First Received: November 4, 2011
Last Updated: September 16, 2013
Health Authority: Egypt: Ministry of Health and Population

Keywords provided by Abbott:
Osteoarthritis
Pain
Morning stiffness

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 14, 2014