Last updated: 04/22/2020 07:40:10
Minimum Clinically Important Improvement following diclofenac sodium gel 1% in knee and hand osteoarthritis.
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Post hoc analyses on the efficacy of diclofenac sodium gel 1% in, vehicle controlled, Knee and Hand Osteoarthritis (Titan Project)
Trial description: The aim of this analysis was to pool data from 3 knee studies and 1 hand study with similar clinical design to investigate the overall efficacy of diclofenac sodium gel 1% in the treatment of knee and hand osteoarthritis after 12 weeks. This post-hoc analysis was planned and conducted after completion of all 4 independent studies.
Primary purpose:
Other
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
To assess minimum Clinically Important Improvement (MCII) Responders Analysis for Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain, WOMAC function, WOMAC stiffness and pain on movement (POM)
Timeframe: At Week 1
To assess MCII Responders Analysis for WOMAC pain, WOMAC function, WOMAC stiffness and POM)
Timeframe: At Week 12
To assess MCII Responders Analysis for pain intensity Visual Analogue Scale (VAS), Australian/Canadian Osteoarthritis Hand Index (AUSCAN) total score, AUSCAN pain, AUSCAN stiffness and AUSCAN function
Timeframe: At Week 1
To assess MCII Responders Analysis for pain intensity VAS, AUSCAN total score, AUSCAN pain, AUSCAN stiffness and AUSCAN function
Timeframe: At Week 4
Secondary outcomes:
To assess the effect of Body Mass Index (BMI) on WOMAC pain, WOMAC function, WOMAC stiffness and POM
Timeframe: At Week 12
Interventions:
Drug: Diclofenac Sodium Gel
Drug: Placebo
Enrollment:
1809
Observational study model:
Cohort
Primary completion date:
2019-26-06
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Osteoarthritis of knee, Pain
Product
diclofenac
Collaborators
Not applicable
Study date(s)
January 2019 to June 2019
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
35 - 92 Years
Accepts healthy volunteers
Yes
- Males and females who are 35 years of age with OA of one or both knees, or ≥ 35 years of age with primary arthritis of hand
- Participants suffering from secondary arthritis, rheumatoid arthritis, and fibromyalgia.
Inclusion and exclusion criteria
Inclusion criteria:
- Males and females who are 35 years of age with OA of one or both knees, or ≥ 35 years of age with primary arthritis of hand
Exclusion criteria:
- Participants suffering from secondary arthritis, rheumatoid arthritis, and fibromyalgia.
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2019-26-06
Actual study completion date
2019-26-06
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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