NCT01066676

Brief Summary

Medical condition under investigation: Osteoarthritis of the hip or knee Number of patients planned: 480 adult patients Main objective: To evaluate and compare the tolerability profile of Dexibuprofen Gebro 400 mg powder for oral suspension compared to Ibuprofen 400 mg in patients with painful osteoarthritis of the hip or knee Secondary objectives: To compare the overall efficacy of Dexibuprofen Gebro 400 mg powder for oral suspension compared to Ibuprofen 400 mg in patients suffering from different complaints due to painful osteoarthritis of the hip or knee

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
482

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2009

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 10, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

July 10, 2012

Status Verified

July 1, 2012

Enrollment Period

2.7 years

First QC Date

February 9, 2010

Last Update Submit

July 9, 2012

Conditions

Osteoarthritis of the Hip or Knee

Outcome Measures

Primary Outcomes (1)

  • Tolerability profile of Dexibuprofen Gebro 400 mg powder for oral suspension compared to Ibuprofen 400 mg in patients with painful osteoarthritis of the hip or knee

    14 days

Secondary Outcomes (1)

  • Overall efficacy of Dexibuprofen Gebro 400 mg powder for oral suspension compared to Ibuprofen 400 mg in patients suffering from different complaints due to painful osteoarthritis of the hip or knee

    14 days

Study Arms (2)

Dexibuprofen

EXPERIMENTAL

Dexibuprofen 400 mg powder for oral suspension

Drug: Dexibuprofen

Ibuprofen

ACTIVE COMPARATOR

Ibuprofen 400 mg powder for oral suspension

Drug: Ibuprofen

Interventions

DexibuprofenDRUG

400mg powder for oral suspension, daily dose 800mg

Dexibuprofen
IbuprofenDRUG

400mg, powder for oral suspension, daily dose 1600mg

Ibuprofen

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male or female patients aged between 18 and 75 years
  • everyday joint pain for the past three months
  • global pain intensity in the involved joint (hip or knee) of "moderate" to "severe" within the last 48 h

You may not qualify if:

  • acute inflammation or ischaemic necrosis
  • paget's disease, chondrocalcinosis, ochronosis of the hip/knee joint
  • slowly progressing hip/knee arthropathy in particular of tuberculosis aetiology
  • hip/knee arthropathy due to diabetes mellitus
  • Charcot's joint
  • villous synovitis
  • chondromatosis of the synovium
  • patients with existing gastritis or existing ulcers or bleedings in the gastrointestinal tract or patients with history of gastrointestinal ulcers or gastrointestinal haemorrhage in the past 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rehabzentrum für Erkrankungen des rheumat. Formenkreises

Bad Hofgastein, Salzburg, 5630, Austria

Location

Rheuma Zentrum Favoriten

Vienna, 1100, Austria

Location

Related Links

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

dexibuprofenIbuprofen

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Reinhold Hawel, MD

    Rehabilitationszentrum, Bad Hofgastein

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2010

First Posted

February 10, 2010

Study Start

October 1, 2009

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

July 10, 2012

Record last verified: 2012-07

Locations

AU(2)