Trial Outcomes & Findings for ALK21-006: Long-Term Study of Medisorb® Naltrexone (VIVITROL®) (NCT NCT01218997)
NCT ID: NCT01218997
Last Updated: 2011-01-04
Results Overview
A TEAE was defined as any adverse event (AE) that started or worsened on or after the administration of the first dose of study medication through 30 days after the end of study treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
436 participants
Primary outcome timeframe
up to 1 year
Results posted on
2011-01-04
Participant Flow
Enrollment was monitored to ensure adequate representation of alcohol-dependent and opioid-dependent patients as defined by Diagnostic and Statistical Manual of Mental Health Disorders (DSM-IV) criteria, and was stratified by alcohol dependence alone versus opioid or mixed substance abuse (ie, alcohol and opioid dependence).
Participant milestones
| Measure |
Medisorb Naltrexone 380 mg (VIVITROL)
Administered once every 4 weeks via intramuscular (IM) injection for up to 1 year.
|
Oral Naltrexone 50 mg
Oral tablet taken once each day for up to 1 year.
|
|---|---|---|
|
Overall Study
STARTED
|
371
|
65
|
|
Overall Study
COMPLETED
|
126
|
24
|
|
Overall Study
NOT COMPLETED
|
245
|
41
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ALK21-006: Long-Term Study of Medisorb® Naltrexone (VIVITROL®)
Baseline characteristics by cohort
| Measure |
Medisorb Naltrexone 380 mg (VIVITROL)
n=371 Participants
Administered once every 4 weeks via intramuscular (IM) injection for up to 1 year.
|
Oral Naltrexone 50 mg
n=65 Participants
Oral tablet taken once each day for up to 1 year.
|
Total
n=436 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
364 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
428 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age Continuous
|
40.7 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
40.5 years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
40.7 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
138 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
161 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
233 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
275 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
371 participants
n=5 Participants
|
65 participants
n=7 Participants
|
436 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 1 yearPopulation: All subjects who received at least 1 dose of study drug are included in the safety population.
A TEAE was defined as any adverse event (AE) that started or worsened on or after the administration of the first dose of study medication through 30 days after the end of study treatment.
Outcome measures
| Measure |
Medisorb Naltrexone 380 mg (VIVITROL)
n=371 Participants
Administered once every 4 weeks via intramuscular (IM) injection for up to 1 year.
|
Oral Naltrexone 50 mg
n=65 Participants
Oral tablet taken once each day for up to 1 year.
|
|---|---|---|
|
Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study
|
336 Participants
|
53 Participants
|
Adverse Events
Medisorb Naltrexone 380 mg (VIVITROL)
Serious events: 49 serious events
Other events: 336 other events
Deaths: 0 deaths
Oral Naltrexone 50 mg
Serious events: 5 serious events
Other events: 53 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Medisorb Naltrexone 380 mg (VIVITROL)
n=371 participants at risk
Administered once every 4 weeks via intramuscular (IM) injection for up to 1 year.
|
Oral Naltrexone 50 mg
n=65 participants at risk
Oral tablet taken once each day for up to 1 year.
|
|---|---|---|
|
Psychiatric disorders
Alcoholism
|
2.7%
10/371 • 1 year
|
4.6%
3/65 • 1 year
|
|
Psychiatric disorders
Drug dependence
|
0.81%
3/371 • 1 year
|
1.5%
1/65 • 1 year
|
|
Psychiatric disorders
Suicidal ideation
|
1.1%
4/371 • 1 year
|
0.00%
0/65 • 1 year
|
|
Psychiatric disorders
Suicide attempt
|
1.1%
4/371 • 1 year
|
0.00%
0/65 • 1 year
|
|
Psychiatric disorders
Depression
|
0.27%
1/371 • 1 year
|
3.1%
2/65 • 1 year
|
|
Psychiatric disorders
Mood disorder NOS
|
0.54%
2/371 • 1 year
|
0.00%
0/65 • 1 year
|
|
Psychiatric disorders
Agitation
|
0.27%
1/371 • 1 year
|
0.00%
0/65 • 1 year
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.27%
1/371 • 1 year
|
0.00%
0/65 • 1 year
|
|
Psychiatric disorders
Delirium
|
0.27%
1/371 • 1 year
|
0.00%
0/65 • 1 year
|
|
Psychiatric disorders
Insomnia
|
0.27%
1/371 • 1 year
|
0.00%
0/65 • 1 year
|
|
Injury, poisoning and procedural complications
Overdose NOS
|
0.54%
2/371 • 1 year
|
0.00%
0/65 • 1 year
|
|
Injury, poisoning and procedural complications
Heat exhaustion
|
0.27%
1/371 • 1 year
|
0.00%
0/65 • 1 year
|
|
Injury, poisoning and procedural complications
Laceration
|
0.27%
1/371 • 1 year
|
0.00%
0/65 • 1 year
|
|
Injury, poisoning and procedural complications
Lower limb fracture NOS
|
0.27%
1/371 • 1 year
|
0.00%
0/65 • 1 year
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.27%
1/371 • 1 year
|
0.00%
0/65 • 1 year
|
|
Injury, poisoning and procedural complications
Non-accidental overdose
|
0.27%
1/371 • 1 year
|
0.00%
0/65 • 1 year
|
|
Injury, poisoning and procedural complications
Postoperative fever
|
0.27%
1/371 • 1 year
|
0.00%
0/65 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
0.27%
1/371 • 1 year
|
0.00%
0/65 • 1 year
|
|
Gastrointestinal disorders
Gastro-oesophageal reflux
|
0.27%
1/371 • 1 year
|
0.00%
0/65 • 1 year
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.27%
1/371 • 1 year
|
0.00%
0/65 • 1 year
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.27%
1/371 • 1 year
|
0.00%
0/65 • 1 year
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.27%
1/371 • 1 year
|
0.00%
0/65 • 1 year
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
0.27%
1/371 • 1 year
|
0.00%
0/65 • 1 year
|
|
Nervous system disorders
Convulsions NOS
|
0.27%
1/371 • 1 year
|
0.00%
0/65 • 1 year
|
|
Nervous system disorders
Ischaemic stroke NOS
|
0.27%
1/371 • 1 year
|
0.00%
0/65 • 1 year
|
|
Nervous system disorders
Transient ischaemic attack
|
0.27%
1/371 • 1 year
|
0.00%
0/65 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive airways disease
|
0.54%
2/371 • 1 year
|
0.00%
0/65 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Asthma NOS
|
0.27%
1/371 • 1 year
|
0.00%
0/65 • 1 year
|
|
Cardiac disorders
Angina unstable
|
0.27%
1/371 • 1 year
|
0.00%
0/65 • 1 year
|
|
Cardiac disorders
Atrial fibrillation
|
0.27%
1/371 • 1 year
|
0.00%
0/65 • 1 year
|
|
General disorders
Chest pain
|
0.27%
1/371 • 1 year
|
0.00%
0/65 • 1 year
|
|
General disorders
Injection site necrosis
|
0.27%
1/371 • 1 year
|
0.00%
0/65 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Bunion
|
0.27%
1/371 • 1 year
|
0.00%
0/65 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Lumbar disc lesion
|
0.27%
1/371 • 1 year
|
0.00%
0/65 • 1 year
|
|
Blood and lymphatic system disorders
Cervical adenitis
|
0.27%
1/371 • 1 year
|
0.00%
0/65 • 1 year
|
|
Infections and infestations
Gastroenteritis NOS
|
0.27%
1/371 • 1 year
|
0.00%
0/65 • 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
0.27%
1/371 • 1 year
|
0.00%
0/65 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer NOS
|
0.27%
1/371 • 1 year
|
0.00%
0/65 • 1 year
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous NOS
|
0.27%
1/371 • 1 year
|
0.00%
0/65 • 1 year
|
|
Social circumstances
Drug abuser NOS
|
0.27%
1/371 • 1 year
|
0.00%
0/65 • 1 year
|
|
Surgical and medical procedures
Coronary arterial stent insertion
|
0.27%
1/371 • 1 year
|
0.00%
0/65 • 1 year
|
|
Vascular disorders
Hypertension NOS
|
0.27%
1/371 • 1 year
|
0.00%
0/65 • 1 year
|
Other adverse events
| Measure |
Medisorb Naltrexone 380 mg (VIVITROL)
n=371 participants at risk
Administered once every 4 weeks via intramuscular (IM) injection for up to 1 year.
|
Oral Naltrexone 50 mg
n=65 participants at risk
Oral tablet taken once each day for up to 1 year.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
20.2%
75/371 • 1 year
|
29.2%
19/65 • 1 year
|
|
Gastrointestinal disorders
Vomiting NOS
|
8.6%
32/371 • 1 year
|
10.8%
7/65 • 1 year
|
|
Gastrointestinal disorders
Diarrhoea NOS
|
4.9%
18/371 • 1 year
|
9.2%
6/65 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain NOS
|
5.1%
19/371 • 1 year
|
4.6%
3/65 • 1 year
|
|
Gastrointestinal disorders
Dyspepsia
|
2.7%
10/371 • 1 year
|
7.7%
5/65 • 1 year
|
|
Infections and infestations
Nasopharyngitis
|
10.8%
40/371 • 1 year
|
16.9%
11/65 • 1 year
|
|
Infections and infestations
Upper respiratory tract infection NOS
|
10.8%
40/371 • 1 year
|
7.7%
5/65 • 1 year
|
|
Infections and infestations
Influenza
|
5.9%
22/371 • 1 year
|
10.8%
7/65 • 1 year
|
|
Infections and infestations
Sinusitis NOS
|
6.5%
24/371 • 1 year
|
4.6%
3/65 • 1 year
|
|
Infections and infestations
Urinary tract infection NOS
|
6.2%
23/371 • 1 year
|
4.6%
3/65 • 1 year
|
|
Psychiatric disorders
Insomnia
|
11.1%
41/371 • 1 year
|
10.8%
7/65 • 1 year
|
|
Psychiatric disorders
Depression
|
9.7%
36/371 • 1 year
|
12.3%
8/65 • 1 year
|
|
Psychiatric disorders
Anxiety NEC
|
7.8%
29/371 • 1 year
|
9.2%
6/65 • 1 year
|
|
Psychiatric disorders
Alcoholism
|
3.0%
11/371 • 1 year
|
6.2%
4/65 • 1 year
|
|
Nervous system disorders
Headache NOS
|
15.6%
58/371 • 1 year
|
16.9%
11/65 • 1 year
|
|
Nervous system disorders
Dizziness
|
8.4%
31/371 • 1 year
|
16.9%
11/65 • 1 year
|
|
General disorders
Fatigue
|
8.9%
33/371 • 1 year
|
16.9%
11/65 • 1 year
|
|
General disorders
Injection site pain
|
8.6%
32/371 • 1 year
|
0.00%
0/65 • 1 year
|
|
General disorders
Influenza like illness
|
5.4%
20/371 • 1 year
|
0.00%
0/65 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.3%
27/371 • 1 year
|
13.8%
9/65 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
23/371 • 1 year
|
7.7%
5/65 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.4%
20/371 • 1 year
|
3.1%
2/65 • 1 year
|
|
Investigations
Blood creatinine phosphokinase increased
|
5.4%
20/371 • 1 year
|
3.1%
2/65 • 1 year
|
|
Injury, poisoning and procedural complications
Laceration
|
2.4%
9/371 • 1 year
|
6.2%
4/65 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Should a PI wish to disclose results, the Sponsor will review the results communications prior to public release and can embargo results communications for a period of at least 30 days prior to the submission, for review and approval. Revisions will be negotiated in good faith by the Investigator and Sponsor and may be submitted for publication or disclosed by the Investigator only following receipt of written approval from the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER