Trial Outcomes & Findings for Efficacy and Safety Study Evaluating ADL5859 and ADL5747 in Participants With Pain Due to Osteoarthritis of the Knee (NCT NCT00979953)
NCT ID: NCT00979953
Last Updated: 2015-08-14
Results Overview
The mean of the daily average scores were calculated from the NPRS pain assessment for the previous 24 hours obtained once a day for at least 4 days from Day -6 through Day 1 (Baseline assessment) and everyday from Day 2 through Day 15 (Treatment Phase assessment). The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
408 participants
Primary outcome timeframe
Baseline, Week 2
Results posted on
2015-08-14
Participant Flow
Participant milestones
| Measure |
ADL5859
One 50-milligrams (mg) ADL5859 capsule, one 100-mg ADL5859 capsule, and 2 placebo capsules administered orally twice daily (BID) for 14 days
|
ADL5747
One 150-mg ADL5747 capsule and 3 placebo capsules administered orally BID for 14 days
|
Oxycodone CR
One 10-mg Oxycodone controlled release (CR) capsule and 3 placebo capsules administered orally BID Days 1 through 4 One 20-mg Oxycodone CR capsule and 3 placebo capsules administered orally BID Days 5 through 14
|
Placebo
Four placebo capsules administered orally BID for 14 days
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
101
|
99
|
104
|
104
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
101
|
99
|
104
|
104
|
|
Overall Study
COMPLETED
|
93
|
94
|
82
|
97
|
|
Overall Study
NOT COMPLETED
|
8
|
5
|
22
|
7
|
Reasons for withdrawal
| Measure |
ADL5859
One 50-milligrams (mg) ADL5859 capsule, one 100-mg ADL5859 capsule, and 2 placebo capsules administered orally twice daily (BID) for 14 days
|
ADL5747
One 150-mg ADL5747 capsule and 3 placebo capsules administered orally BID for 14 days
|
Oxycodone CR
One 10-mg Oxycodone controlled release (CR) capsule and 3 placebo capsules administered orally BID Days 1 through 4 One 20-mg Oxycodone CR capsule and 3 placebo capsules administered orally BID Days 5 through 14
|
Placebo
Four placebo capsules administered orally BID for 14 days
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
5
|
2
|
17
|
4
|
|
Overall Study
Lack of Efficacy
|
1
|
2
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
2
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
2
|
2
|
Baseline Characteristics
Efficacy and Safety Study Evaluating ADL5859 and ADL5747 in Participants With Pain Due to Osteoarthritis of the Knee
Baseline characteristics by cohort
| Measure |
ADL5859
n=101 Participants
One 50-mg ADL5859 capsule, one 100-mg ADL5859 capsule, and 2 placebo capsules administered orally BID for 14 days
|
ADL5747
n=99 Participants
One 150-mg ADL5747 capsule and 3 placebo capsules administered orally BID for 14 days
|
Oxycodone CR
n=104 Participants
One 10-mg Oxycodone CR capsule and 3 placebo capsules administered orally BID Days 1 through 4
One 20-mg Oxycodone CR capsule and 3 placebo capsules administered orally BID Days 5 through 14
|
Placebo
n=104 Participants
Four placebo capsules administered orally BID for 14 days
|
Total
n=408 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
56.5 years
STANDARD_DEVIATION 8.15 • n=5 Participants
|
57.3 years
STANDARD_DEVIATION 8.74 • n=7 Participants
|
57.8 years
STANDARD_DEVIATION 8.39 • n=5 Participants
|
56.5 years
STANDARD_DEVIATION 8.11 • n=4 Participants
|
57.0 years
STANDARD_DEVIATION 8.34 • n=21 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
240 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
168 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 2Population: All participants who received at least 1 dose of study medication and had at least evaluable 1 NPRS postdose measurement. Last-observation-carried-forward (LOCF) was used to impute missing postbaseline values.
The mean of the daily average scores were calculated from the NPRS pain assessment for the previous 24 hours obtained once a day for at least 4 days from Day -6 through Day 1 (Baseline assessment) and everyday from Day 2 through Day 15 (Treatment Phase assessment). The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain.
Outcome measures
| Measure |
Placebo
n=103 Participants
Four placebo capsules administered orally BID for 14 days
|
Oxycodone CR
n=100 Participants
One 10-mg Oxycodone CR capsule and 3 placebo capsules administered orally BID Days 1 through 4
One 20-mg Oxycodone CR capsule and 3 placebo capsules administered orally BID for Days 5 through 14
|
ADL5747
n=99 Participants
One 150-mg ADL5747 capsule and 3 placebo capsules administered orally BID for 14 days
|
ADL5859
n=101 Participants
One 50-mg ADL5859 capsule, one 100-mg ADL5859 capsule, and 2 placebo capsules administered orally BID for 14 days
|
|---|---|---|---|---|
|
Change From Baseline in the Average Pain Score (NPRS) for Week 2
|
-2.20 units on a scale
Standard Deviation 2.088
|
-2.24 units on a scale
Standard Deviation 2.162
|
-1.57 units on a scale
Standard Deviation 1.656
|
-1.77 units on a scale
Standard Deviation 1.776
|
Adverse Events
ADL5859
Serious events: 2 serious events
Other events: 50 other events
Deaths: 0 deaths
ADL5747
Serious events: 1 serious events
Other events: 40 other events
Deaths: 0 deaths
Oxycodone CR
Serious events: 0 serious events
Other events: 75 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ADL5859
n=101 participants at risk
One 50-mg ADL5859 capsule, one 100-mg ADL5859 capsule, and 2 placebo capsules administered orally BID for 14 days
|
ADL5747
n=99 participants at risk
One 150-mg ADL5747 capsule and 3 placebo capsules administered orally BID for 14 days
|
Oxycodone CR
n=104 participants at risk
One 10-mg Oxycodone CR capsule and 3 placebo capsules administered orally BID Days 1 through 4
One 20-mg Oxycodone CR capsule and 3 placebo capsules administered orally BID Days 5 through 14
|
Placebo
n=104 participants at risk
Four placebo capsules administered orally BID for 14 days
|
|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/101
|
0.00%
0/99
|
0.00%
0/104
|
0.96%
1/104
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
0.99%
1/101
|
0.00%
0/99
|
0.00%
0/104
|
0.00%
0/104
|
|
Nervous system disorders
Cerebral Haemorrhage
|
0.00%
0/101
|
1.0%
1/99
|
0.00%
0/104
|
0.00%
0/104
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease (COPD)
|
0.99%
1/101
|
0.00%
0/99
|
0.00%
0/104
|
0.00%
0/104
|
Other adverse events
| Measure |
ADL5859
n=101 participants at risk
One 50-mg ADL5859 capsule, one 100-mg ADL5859 capsule, and 2 placebo capsules administered orally BID for 14 days
|
ADL5747
n=99 participants at risk
One 150-mg ADL5747 capsule and 3 placebo capsules administered orally BID for 14 days
|
Oxycodone CR
n=104 participants at risk
One 10-mg Oxycodone CR capsule and 3 placebo capsules administered orally BID Days 1 through 4
One 20-mg Oxycodone CR capsule and 3 placebo capsules administered orally BID Days 5 through 14
|
Placebo
n=104 participants at risk
Four placebo capsules administered orally BID for 14 days
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
7.9%
8/101
|
5.1%
5/99
|
28.8%
30/104
|
3.8%
4/104
|
|
Gastrointestinal disorders
Diarrhea
|
5.0%
5/101
|
7.1%
7/99
|
2.9%
3/104
|
0.96%
1/104
|
|
Gastrointestinal disorders
Dry mouth
|
7.9%
8/101
|
6.1%
6/99
|
12.5%
13/104
|
5.8%
6/104
|
|
Gastrointestinal disorders
Nausea
|
5.0%
5/101
|
5.1%
5/99
|
30.8%
32/104
|
3.8%
4/104
|
|
Gastrointestinal disorders
Vomiting
|
0.99%
1/101
|
0.00%
0/99
|
14.4%
15/104
|
0.00%
0/104
|
|
General disorders
Fatigue
|
5.9%
6/101
|
2.0%
2/99
|
16.3%
17/104
|
6.7%
7/104
|
|
Nervous system disorders
Dizziness
|
4.0%
4/101
|
1.0%
1/99
|
16.3%
17/104
|
1.9%
2/104
|
|
Nervous system disorders
Headache
|
9.9%
10/101
|
10.1%
10/99
|
12.5%
13/104
|
2.9%
3/104
|
|
Nervous system disorders
Somnolence
|
6.9%
7/101
|
4.0%
4/99
|
19.2%
20/104
|
7.7%
8/104
|
|
Psychiatric disorders
Disturbance in attention
|
2.0%
2/101
|
0.00%
0/99
|
7.7%
8/104
|
0.00%
0/104
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.99%
1/101
|
0.00%
0/99
|
16.3%
17/104
|
1.9%
2/104
|
Additional Information
VP of Clinical Research
Cubist Pharmaceuticals
Phone: (781) 860-8660
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER