Trial Outcomes & Findings for Study of Embeda (Kadian NT, ALO-01) in Subjects With Chronic Moderate to Severe Nonmalignant Pain (NCT NCT00415597)
NCT ID: NCT00415597
Last Updated: 2013-09-20
Results Overview
Number of subjects with adverse events (any unfavorable and unintended sign, symptom, or disease temporally associated with the use of the product whether or not related to the product).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
467 participants
Primary outcome timeframe
up to 12 months
Results posted on
2013-09-20
Participant Flow
Participant milestones
| Measure |
ALO-01
|
|---|---|
|
Enrollment
STARTED
|
467
|
|
Enrollment
COMPLETED
|
465
|
|
Enrollment
NOT COMPLETED
|
2
|
|
Treatment
STARTED
|
465
|
|
Treatment
COMPLETED
|
160
|
|
Treatment
NOT COMPLETED
|
305
|
Reasons for withdrawal
| Measure |
ALO-01
|
|---|---|
|
Enrollment
Withdrawal by Subject
|
1
|
|
Enrollment
Protocol Violation
|
1
|
|
Treatment
Adverse Event
|
110
|
|
Treatment
Lack of Efficacy
|
39
|
|
Treatment
Protocol Violation
|
67
|
|
Treatment
Physician Decision
|
3
|
|
Treatment
Withdrawal by Subject
|
51
|
|
Treatment
Lost to Follow-up
|
28
|
|
Treatment
Drug Screen
|
2
|
|
Treatment
Administrative
|
3
|
|
Treatment
Sponsor Decision
|
1
|
|
Treatment
Multiple Reasons
|
1
|
Baseline Characteristics
Study of Embeda (Kadian NT, ALO-01) in Subjects With Chronic Moderate to Severe Nonmalignant Pain
Baseline characteristics by cohort
| Measure |
ALO-01
n=465 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
417 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
48 Participants
n=5 Participants
|
|
Age Continuous
|
51.7 years
STANDARD_DEVIATION 10.56 • n=5 Participants
|
|
Sex: Female, Male
Female
|
245 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
220 Participants
n=5 Participants
|
|
Brief Pain Inventory (BPI) Average Pain
|
6.0 Units on scale
STANDARD_DEVIATION 1.67 • n=5 Participants
|
PRIMARY outcome
Timeframe: up to 12 monthsPopulation: Patients treated with study drug
Number of subjects with adverse events (any unfavorable and unintended sign, symptom, or disease temporally associated with the use of the product whether or not related to the product).
Outcome measures
| Measure |
ALO-01
n=465 Participants
|
|---|---|
|
Subjects With Treatment Emergent Adverse Events
|
378 participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Patients with data at Week 12
Percent change in pain intensity scale. Average pain intensity over last 24 hours rated at each visit from 0=no pain to 10=worst pain.
Outcome measures
| Measure |
ALO-01
n=254 Participants
|
|---|---|
|
Mean Percent Change From Baseline to 12 Weeks in Brief Pain Inventory Score (BPI) of Average Pain
|
-31.3 Percent change
Standard Deviation 37.44
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Patients with data at Week 52
Percent change in pain intensity scale. Average pain intensity over last 24 hours rated at each visit from 0=no pain to 10=worst pain.
Outcome measures
| Measure |
ALO-01
n=162 Participants
|
|---|---|
|
Mean Percent Change From Baseline to 52 Weeks in Brief Pain Inventory Score (BPI) of Average Pain
|
-41.5 Percent change
Standard Deviation 39.28
|
Adverse Events
ALO-01
Serious events: 33 serious events
Other events: 265 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ALO-01
n=465 participants at risk
|
|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.22%
1/465 • Number of events 1
|
|
Cardiac disorders
Angina pectoris
|
0.22%
1/465 • Number of events 1
|
|
Cardiac disorders
Cardiac failure congestive
|
0.22%
1/465 • Number of events 1
|
|
Cardiac disorders
Coronary artery disease
|
0.22%
1/465 • Number of events 1
|
|
Gastrointestinal disorders
Colitis
|
0.43%
2/465 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhoea
|
0.22%
1/465 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.22%
1/465 • Number of events 1
|
|
Gastrointestinal disorders
Pancreatitis
|
0.22%
1/465 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.22%
1/465 • Number of events 1
|
|
General disorders
Chest pain
|
0.43%
2/465 • Number of events 2
|
|
General disorders
Pyrexia
|
0.22%
1/465 • Number of events 1
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.22%
1/465 • Number of events 1
|
|
Infections and infestations
Arthritis bacterial
|
0.43%
2/465 • Number of events 2
|
|
Infections and infestations
Pyelonephritis acute
|
0.22%
1/465 • Number of events 1
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.22%
1/465 • Number of events 1
|
|
Injury, poisoning and procedural complications
Overdose (insulin)
|
0.22%
1/465 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.22%
1/465 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.22%
1/465 • Number of events 1
|
|
Metabolism and nutrition disorders
Ketosis
|
0.22%
1/465 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.22%
1/465 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Invertebral disc protrusion
|
0.22%
1/465 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.43%
2/465 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.22%
1/465 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage I
|
0.22%
1/465 • Number of events 1
|
|
Nervous system disorders
Carotid artery stenosis
|
0.22%
1/465 • Number of events 1
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.22%
1/465 • Number of events 2
|
|
Nervous system disorders
Transient ischaemic attack
|
0.22%
1/465 • Number of events 1
|
|
Psychiatric disorders
Conversion disorder
|
0.22%
1/465 • Number of events 1
|
|
Psychiatric disorders
Somatoform disorder
|
0.22%
1/465 • Number of events 1
|
|
Psychiatric disorders
Suicidal ideation
|
0.22%
1/465 • Number of events 1
|
|
Surgical and medical procedures
Appendicectomy
|
0.22%
1/465 • Number of events 1
|
|
Surgical and medical procedures
Hip surgery
|
0.22%
1/465 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis
|
0.43%
2/465 • Number of events 2
|
|
Vascular disorders
Peripheral vascular disorder
|
0.22%
1/465 • Number of events 1
|
Other adverse events
| Measure |
ALO-01
n=465 participants at risk
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
31.8%
148/465
|
|
Gastrointestinal disorders
Nausea
|
25.2%
117/465
|
|
Gastrointestinal disorders
Vomiting
|
11.6%
54/465
|
|
Gastrointestinal disorders
Diarrhoea
|
7.5%
35/465
|
|
General disorders
Fatigue
|
6.2%
29/465
|
|
Nervous system disorders
Headache
|
12.0%
56/465
|
|
Nervous system disorders
Somnolence
|
7.7%
36/465
|
|
Psychiatric disorders
Insomnia
|
5.8%
27/465
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
29/465
|
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