Trial Outcomes & Findings for Efficacy of Lodotra®(Prednisone) in Reduction of Morning Stiffness Duration(K-IMPROvE) (NCT NCT02072200)
NCT ID: NCT02072200
Last Updated: 2016-08-08
Results Overview
Data for the duration of morning stiffness will be obtained from patient diaries. Duration of morning stiffness will be from wake-up time to time of resolution of morning stiffness. Relative reduction rate of the morning stiffness duration from baseline to Week 12 of the study drug treatment was calculated for this outcome measure.
COMPLETED
PHASE4
147 participants
Baseline and 12 weeks
2016-08-08
Participant Flow
Participant milestones
| Measure |
Modified Release Prednisone
Single arm / Lodotra
Lodotra®: Single arm will be received below oral 10mg tablet daily and maximum 10mg/d depending on the clinical symptoms and the patient's response
|
|---|---|
|
Overall Study
STARTED
|
147
|
|
Overall Study
COMPLETED
|
145
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of Lodotra®(Prednisone) in Reduction of Morning Stiffness Duration(K-IMPROvE)
Baseline characteristics by cohort
| Measure |
Modified Release Prednisone
n=145 Participants
Single arm / Lodotra
Lodotra®: Single arm will be received below oral 10mg tablet daily and maximum 10mg/d depending on the clinical symptoms and the patient's response
|
|---|---|
|
Age, Continuous
|
55.41 participant
STANDARD_DEVIATION 11.79 • n=5 Participants
|
|
Sex: Female, Male
Female
|
113 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
145 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksPopulation: ITT set = 145 patients. Missing data was handled as LOCF.
Data for the duration of morning stiffness will be obtained from patient diaries. Duration of morning stiffness will be from wake-up time to time of resolution of morning stiffness. Relative reduction rate of the morning stiffness duration from baseline to Week 12 of the study drug treatment was calculated for this outcome measure.
Outcome measures
| Measure |
Modified Release Prednisone
n=145 Participants
Single arm / Lodotra
Lodotra®: Single arm will be received below oral 10mg tablet daily and maximum 10mg/d depending on the clinical symptoms and the patient's response
|
|---|---|
|
Change From Baseline in Morning Stiffness Duration at Week 12 as Assessed by Patient Diary
|
-16.76 minutes
Standard Deviation 3.352
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: ITT population was 145, but 3 patients were not assessed for primary efficacy parameter of morning stiffness severity. So, Last Observation Carried Forward (LOCF) was not done for these 3 patients after baseline . Other patients' missing data were handled using LOCF method.
The VAS is a 100 mm line ranging from 0 mm (no pain) on the left end and 100 mm (worst pain) on the right end. Subjects marked on the line to indicate their pain severity. The distance in mm was measured from the left end to the subject's marking.
Outcome measures
| Measure |
Modified Release Prednisone
n=142 Participants
Single arm / Lodotra
Lodotra®: Single arm will be received below oral 10mg tablet daily and maximum 10mg/d depending on the clinical symptoms and the patient's response
|
|---|---|
|
Change of Baseline Severity of Morning Stiffness at Week 12 Using Visual Analog Scale (VAS) Scale
|
-25.70 mm
Standard Deviation 25.87
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: ITT set was 145 patients, but 11 patients data was not assessed except baseline score.
Change in KHAQ score from baseline to Week 12 post-treatment: KHAQ is composed of 8 functional disability indices. The scale for each index is from 0 (without any difficulty) to 3 (unable to do). Scores for each disability index were summed to obtain the total score for each subject, ranging between 0 to 24, with higher scores reflecting higher functional disability. The scores were then averaged across all subjects.
Outcome measures
| Measure |
Modified Release Prednisone
n=134 Participants
Single arm / Lodotra
Lodotra®: Single arm will be received below oral 10mg tablet daily and maximum 10mg/d depending on the clinical symptoms and the patient's response
|
|---|---|
|
Change of Functional Disability Index of the Korea Health Assessment Questionnaire (KHAQ) From Baseline to Week 12
|
-4.76 scores on a scale
Standard Deviation 8.16
|
Adverse Events
Modified Release Prednisone
Serious adverse events
| Measure |
Modified Release Prednisone
n=145 participants at risk
Single arm / Lodotra
Lodotra®: Single arm will be received below oral 10mg tablet daily and maximum 10mg/d depending on the clinical symptoms and the patient's response
|
|---|---|
|
Infections and infestations
Herpes zoster
|
0.69%
1/145 • 12 weeks
|
|
Infections and infestations
Pneumonia
|
0.69%
1/145 • 12 weeks
|
|
Infections and infestations
Sepsis
|
0.69%
1/145 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.69%
1/145 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.69%
1/145 • 12 weeks
|
Other adverse events
| Measure |
Modified Release Prednisone
n=145 participants at risk
Single arm / Lodotra
Lodotra®: Single arm will be received below oral 10mg tablet daily and maximum 10mg/d depending on the clinical symptoms and the patient's response
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
4.1%
6/145 • 12 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
2.8%
4/145 • 12 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.1%
3/145 • 12 weeks
|
|
Gastrointestinal disorders
Nausea
|
2.1%
3/145 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.1%
3/145 • 12 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
1.4%
2/145 • 12 weeks
|
|
Gastrointestinal disorders
Diarrhoea, vomiting, constipation, gastric disorder, gastritis, gastrointestinal disorder
|
5.5%
8/145 • 12 weeks
|
|
Infections and infestations
Bronchitis, cellulitis, conjunctivitis, folliculitis, rhinitis
|
3.4%
5/145 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint swelling, musculoskeletal pain, neck pain, pain in extremity, synovial cyst
|
3.4%
5/145 • 12 weeks
|
|
General disorders
Face edema, edema, pain, pyrexia, oedma peripheral
|
5.5%
8/145 • 12 weeks
|
|
Investigations
Alanine aminotransferase increased, aspartate aminotransferase increased, blood glucose increased
|
2.1%
3/145 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia, onychoclasis, rash, urticaria
|
2.8%
4/145 • 12 weeks
|
|
Eye disorders
Cataract, dry eye, eyelid edema, vision blurred
|
2.8%
4/145 • 12 weeks
|
|
Injury, poisoning and procedural complications
Humerus fracture, thoracic vertebral fracture
|
1.4%
2/145 • 12 weeks
|
|
Metabolism and nutrition disorders
Hyperlipedemia
|
1.4%
2/145 • 12 weeks
|
|
Nervous system disorders
Headache
|
1.4%
2/145 • 12 weeks
|
|
Ear and labyrinth disorders
Tinnitus
|
0.69%
1/145 • 12 weeks
|
|
Psychiatric disorders
Insomnia
|
0.69%
1/145 • 12 weeks
|
|
Renal and urinary disorders
Dysuria
|
0.69%
1/145 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI/ Institution shall provide to Mundipharma any proposed presentation at least 15 working days prior to being disclosed and any other proposed publication at least 45 working days prior to being disclosed. Mundipharma may in its sole discretion permit such publications and presentations and shall have the right to require amendments to any such proposed presentation or publication on reasonable grounds.
- Publication restrictions are in place
Restriction type: OTHER