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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 14, 2014