Trial Outcomes & Findings for A Study of Embeda (Kadian NT, ALO-01) in Subjects With Pain Due to Osteoarthritis of the Hip or Knee (NCT NCT00420992)
NCT ID: NCT00420992
Last Updated: 2013-09-20
Results Overview
Change in pain intensity scale. Average pain intensity over last 24 hours rated daily from 0=no pain to 10=worst pain.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
547 participants
Primary outcome timeframe
randomization to 12 weeks following randomization
Results posted on
2013-09-20
Participant Flow
Participant milestones
| Measure |
ALO-01
|
Placebo
|
|---|---|---|
|
Titration Phase
STARTED
|
547
|
0
|
|
Titration Phase
COMPLETED
|
344
|
0
|
|
Titration Phase
NOT COMPLETED
|
203
|
0
|
|
Maintenance Phase
STARTED
|
171
|
173
|
|
Maintenance Phase
COMPLETED
|
110
|
98
|
|
Maintenance Phase
NOT COMPLETED
|
61
|
75
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Embeda (Kadian NT, ALO-01) in Subjects With Pain Due to Osteoarthritis of the Hip or Knee
Baseline characteristics by cohort
| Measure |
ALO-01
n=171 Participants
|
Placebo
n=173 Participants
|
Total
n=344 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
54.2 years
STANDARD_DEVIATION 11.62 • n=5 Participants
|
54.7 years
STANDARD_DEVIATION 12.92 • n=7 Participants
|
54.4 years
STANDARD_DEVIATION 12.27 • n=5 Participants
|
|
Sex: Female, Male
Female
|
106 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
201 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: randomization to 12 weeks following randomizationPopulation: intent to treat (ITT)
Change in pain intensity scale. Average pain intensity over last 24 hours rated daily from 0=no pain to 10=worst pain.
Outcome measures
| Measure |
ALO-01
n=170 Participants
|
Placebo
n=173 Participants
|
|---|---|---|
|
Mean Change From Randomization to 12 Weeks Following Randomization in Diary Brief Pain Inventory Score of Average Pain (Daily Scores of Average Pain Averaged Over 7 Days)
|
-0.2 units on scale
Standard Deviation 1.94
|
0.3 units on scale
Standard Deviation 2.05
|
Adverse Events
ALO-01
Serious events: 6 serious events
Other events: 54 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 48 other events
Deaths: 0 deaths
Titration ALO-01
Serious events: 3 serious events
Other events: 301 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ALO-01
n=171 participants at risk
|
Placebo
n=173 participants at risk
|
Titration ALO-01
n=547 participants at risk
Open-label ALO-01
|
|---|---|---|---|
|
Vascular disorders
Hypotension
|
0.00%
0/171
|
0.00%
0/173
|
0.18%
1/547 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/171
|
0.00%
0/173
|
0.18%
1/547 • Number of events 1
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/171
|
0.00%
0/173
|
0.18%
1/547 • Number of events 1
|
|
General disorders
Chest pain
|
0.00%
0/171
|
0.58%
1/173 • Number of events 1
|
0.00%
0/547
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/171
|
0.58%
1/173 • Number of events 1
|
0.00%
0/547
|
|
Gastrointestinal disorders
Pancreatitis
|
0.58%
1/171 • Number of events 1
|
0.00%
0/173
|
0.00%
0/547
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/171
|
0.58%
1/173 • Number of events 1
|
0.00%
0/547
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma stage unspecified
|
0.58%
1/171 • Number of events 1
|
0.00%
0/173
|
0.00%
0/547
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.58%
1/171 • Number of events 1
|
0.00%
0/173
|
0.00%
0/547
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.58%
1/171 • Number of events 1
|
0.00%
0/173
|
0.00%
0/547
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.58%
1/171 • Number of events 1
|
0.00%
0/173
|
0.00%
0/547
|
|
Infections and infestations
Gastroenteritis viral
|
0.58%
1/171 • Number of events 1
|
0.00%
0/173
|
0.00%
0/547
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.58%
1/171 • Number of events 1
|
0.00%
0/173
|
0.00%
0/547
|
Other adverse events
| Measure |
ALO-01
n=171 participants at risk
|
Placebo
n=173 participants at risk
|
Titration ALO-01
n=547 participants at risk
Open-label ALO-01
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
7.0%
12/171
|
4.0%
7/173
|
30.5%
167/547
|
|
Gastrointestinal disorders
Diarrhoea
|
12.3%
21/171
|
12.1%
21/173
|
2.7%
15/547
|
|
Gastrointestinal disorders
Nausea
|
11.7%
20/171
|
7.5%
13/173
|
21.0%
115/547
|
|
Gastrointestinal disorders
Dry mouth
|
1.8%
3/171
|
1.2%
2/173
|
5.7%
31/547
|
|
Gastrointestinal disorders
Vomiting
|
7.0%
12/171
|
2.3%
4/173
|
9.1%
50/547
|
|
Nervous system disorders
Somnolence
|
1.2%
2/171
|
2.9%
5/173
|
14.3%
78/547
|
|
Nervous system disorders
Dizziness
|
1.8%
3/171
|
1.7%
3/173
|
8.6%
47/547
|
|
Nervous system disorders
Headache
|
7.0%
12/171
|
3.5%
6/173
|
6.0%
33/547
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.58%
1/171
|
0.58%
1/173
|
6.9%
38/547
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.3%
4/171
|
6.9%
12/173
|
0.37%
2/547
|
Additional Information
Vice President, Clinical Development
King Pharmaceuticals Research and Development, Inc.
Phone: 919-653-7001
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the Sponsor for review. Sponsor may request a delay in publication to allow the filing of patent applications before publication or release. The sponsor can require deletion of Confidential Information or request correction of inaccuracies.
- Publication restrictions are in place
Restriction type: OTHER