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Trial Outcomes & Findings for CRx-102 Osteoarthritis Multicenter Evaluation Trial (NCT NCT00521989)

NCT ID: NCT00521989

Last Updated: 2014-04-29

Results Overview

The WOMAC Index is a validated, 24-question self-administered assessment of three dimensions of pain, stiffness, and physical function for subjects with knee or hip OA. The WOMAC pain question #1 asks subjects to "think about the pain you felt in your (study joint) caused by your arthritis during the last 48 hours when walking on a flat surface." This is a visual analog scale (VAS) where the subject indicates pain severity by making a mark through a 100 mm horizontal line with "No Pain" on the left (0 mm) and "Extreme Pain" on the right (100 mm). The distance between the left end of the scale and the subject's mark is measured in millimeters. Lower values represent a better outcome.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

279 participants

Primary outcome timeframe

Baseline to Day 98

Results posted on

2014-04-29

Participant Flow

Participant milestones

Participant milestones
Measure
CRx-102 (2.7/90 mg)
CRx-102 (Prednisolone 2.7 mg + Dipyridamole 90 mg) prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)
CRx-102 (2.7/180 mg)
CRx-102 Dose 2 (2.7 mg prednisolone + 180 mg dipyridamole) prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)
CRx-102 (2.7/360 mg)
CRx-102 Dose 3 (2.7 mg prednisolone + 360 mg dipyridamole) prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)
Prednisolone
Prednisolone 2.7 mg Prednisolone: Prednisolone
Placebo
Placebo Placebo: Placebo
Overall Study
STARTED
56
54
57
54
58
Overall Study
COMPLETED
36
37
41
42
35
Overall Study
NOT COMPLETED
20
17
16
12
23

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

CRx-102 Osteoarthritis Multicenter Evaluation Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
CRx-102 (2.7/90 mg)
n=56 Participants
CRx-102 (Prednisolone 2.7 mg + Dipyridamole 90 mg) prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)
CRx-102 (2.7/180 mg)
n=54 Participants
CRx-102 Dose 2 (2.7 mg prednisolone + 180 mg dipyridamole) prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)
CRx-102 (2.7/360 mg)
n=57 Participants
CRx-102 Dose 3 (2.7 mg prednisolone + 360 mg dipyridamole) prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)
Prednisolone
n=54 Participants
Prednisolone 2.7 mg Prednisolone: Prednisolone
Placebo
n=58 Participants
Placebo Placebo: Placebo
Total
n=279 Participants
Total of all reporting groups
Age, Continuous
61.1 years
STANDARD_DEVIATION 9.35 • n=5 Participants
59.4 years
STANDARD_DEVIATION 10.02 • n=7 Participants
57.7 years
STANDARD_DEVIATION 9.03 • n=5 Participants
60.2 years
STANDARD_DEVIATION 8.65 • n=4 Participants
57.9 years
STANDARD_DEVIATION 7.46 • n=21 Participants
59.3 years
STANDARD_DEVIATION 8.96 • n=10 Participants
Sex: Female, Male
Female
37 Participants
n=5 Participants
33 Participants
n=7 Participants
38 Participants
n=5 Participants
30 Participants
n=4 Participants
37 Participants
n=21 Participants
175 Participants
n=10 Participants
Sex: Female, Male
Male
19 Participants
n=5 Participants
21 Participants
n=7 Participants
19 Participants
n=5 Participants
24 Participants
n=4 Participants
21 Participants
n=21 Participants
104 Participants
n=10 Participants

PRIMARY outcome

Timeframe: Baseline to Day 98

Population: ITT population

The WOMAC Index is a validated, 24-question self-administered assessment of three dimensions of pain, stiffness, and physical function for subjects with knee or hip OA. The WOMAC pain question #1 asks subjects to "think about the pain you felt in your (study joint) caused by your arthritis during the last 48 hours when walking on a flat surface." This is a visual analog scale (VAS) where the subject indicates pain severity by making a mark through a 100 mm horizontal line with "No Pain" on the left (0 mm) and "Extreme Pain" on the right (100 mm). The distance between the left end of the scale and the subject's mark is measured in millimeters. Lower values represent a better outcome.

Outcome measures

Outcome measures
Measure
CRx-102 (2.7/90 mg)
n=56 Participants
CRx-102 (Prednisolone 2.7 mg + Dipyridamole 90 mg) prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)
CRx-102 (2.7/180 mg)
n=54 Participants
CRx-102 Dose 2 (2.7 mg prednisolone + 180 mg dipyridamole) prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)
CRx-102 (2.7/360 mg)
n=57 Participants
CRx-102 Dose 3 (2.7 mg prednisolone + 360 mg dipyridamole) prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)
Prednisolone
n=54 Participants
Prednisolone 2.7 mg Prednisolone: Prednisolone
Placebo
n=58 Participants
Placebo Placebo: Placebo
Change From Baseline to Day 98 Using the WOMAC Pain Question #1
-32.4 millimeters
Standard Deviation 27.07
-33.2 millimeters
Standard Deviation 32.02
-37.3 millimeters
Standard Deviation 33.07
-40.4 millimeters
Standard Deviation 30.04
-34.6 millimeters
Standard Deviation 27.11

SECONDARY outcome

Timeframe: Day 98

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths

Prednisolone

Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths

CRx-102 (2.7/90 mg)

Serious events: 2 serious events
Other events: 29 other events
Deaths: 0 deaths

CRx-102 (2.7/180 mg)

Serious events: 1 serious events
Other events: 29 other events
Deaths: 0 deaths

CRx-102 (2.7/360 mg)

Serious events: 1 serious events
Other events: 40 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Placebo
n=58 participants at risk
Placebo
Prednisolone
n=54 participants at risk
Prednisolone 2.7 mg
CRx-102 (2.7/90 mg)
n=56 participants at risk
CRx-102 dose 1 (2.7 mg prednisolone + 90 mg dipyridamole)
CRx-102 (2.7/180 mg)
n=54 participants at risk
CRx-102 dose 2 (2.7 mg prednisolone + 180 mg dipyridamole)
CRx-102 (2.7/360 mg)
n=57 participants at risk
CRx-102 dose 3 (2.7 mg prednisolone + 360 mg dipyridamole)
Hepatobiliary disorders
Cholelithiasis
0.00%
0/58
1.9%
1/54
1.8%
1/56
0.00%
0/54
0.00%
0/57
Ear and labyrinth disorders
Vertigo
0.00%
0/58
0.00%
0/54
1.8%
1/56
0.00%
0/54
0.00%
0/57
Psychiatric disorders
Hallucination, auditory
1.7%
1/58
0.00%
0/54
0.00%
0/56
0.00%
0/54
0.00%
0/57
General disorders
Chest Pain
0.00%
0/58
0.00%
0/54
0.00%
0/56
0.00%
0/54
1.8%
1/57
Hepatobiliary disorders
Cholecystitis acute
0.00%
0/58
0.00%
0/54
0.00%
0/56
1.9%
1/54
0.00%
0/57

Other adverse events

Other adverse events
Measure
Placebo
n=58 participants at risk
Placebo
Prednisolone
n=54 participants at risk
Prednisolone 2.7 mg
CRx-102 (2.7/90 mg)
n=56 participants at risk
CRx-102 dose 1 (2.7 mg prednisolone + 90 mg dipyridamole)
CRx-102 (2.7/180 mg)
n=54 participants at risk
CRx-102 dose 2 (2.7 mg prednisolone + 180 mg dipyridamole)
CRx-102 (2.7/360 mg)
n=57 participants at risk
CRx-102 dose 3 (2.7 mg prednisolone + 360 mg dipyridamole)
Nervous system disorders
Headache
17.2%
10/58
25.9%
14/54
28.6%
16/56
31.5%
17/54
49.1%
28/57
Gastrointestinal disorders
Diarrhea
5.2%
3/58
7.4%
4/54
3.6%
2/56
7.4%
4/54
5.3%
3/57
Gastrointestinal disorders
Nausea
6.9%
4/58
5.6%
3/54
0.00%
0/56
7.4%
4/54
5.3%
3/57
Musculoskeletal and connective tissue disorders
Back Pain
1.7%
1/58
5.6%
3/54
1.8%
1/56
1.9%
1/54
7.0%
4/57
Infections and infestations
Upper respiratory tract infection
1.7%
1/58
0.00%
0/54
7.1%
4/56
1.9%
1/54
1.8%
1/57
Infections and infestations
Urinary tract infection
0.00%
0/58
1.9%
1/54
5.4%
3/56
3.7%
2/54
1.8%
1/57
General disorders
Fatigue
0.00%
0/58
1.9%
1/54
5.4%
3/56
1.9%
1/54
0.00%
0/57

Additional Information

Margaret Lee, PhD

Zalicus

Phone: 617-301-7142

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: GT60