Trial Outcomes & Findings for ALK21-021: A Safety Study of Medisorb® Naltrexone (VIVITROL®) Administered to Health Care Professionals (NCT NCT00834080)
NCT ID: NCT00834080
Last Updated: 2018-12-11
Results Overview
A TEAE is any adverse event (AE), whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
38 participants
Primary outcome timeframe
2 years (Baseline to end of study)
Results posted on
2018-12-11
Participant Flow
This study had a 12 month recruitment period (May 2009 through April 2010). A total of 11 sites in the United States participated. Principal Investigators were addiction specialists who had contact with health care professionals in need of treatment for opioid dependence.
Potential subjects must have participated in a detoxification program for opioid dependence. Subjects participated in psychosocial treatment throughout their study participation.
Participant milestones
| Measure |
VIVITROL
Study drug was administered by intramuscular (IM) injection once monthly for 24 months.
|
|---|---|
|
Overall Study
STARTED
|
38
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
23
|
Reasons for withdrawal
| Measure |
VIVITROL
Study drug was administered by intramuscular (IM) injection once monthly for 24 months.
|
|---|---|
|
Overall Study
Adverse Event
|
7
|
|
Overall Study
Lost to Follow-up
|
7
|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
Other - Pregnancy
|
1
|
|
Overall Study
Other - False positive tests of the UDS
|
1
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Subject Relocated
|
1
|
Baseline Characteristics
ALK21-021: A Safety Study of Medisorb® Naltrexone (VIVITROL®) Administered to Health Care Professionals
Baseline characteristics by cohort
| Measure |
VIVITROL, 380mg
n=38 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
42.4 years
STANDARD_DEVIATION 10.39 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 years (Baseline to end of study)Population: The Safety Population, defined as all subjects who received at least 1 dose (injection) of study drug, was used for presentation and analysis of both safety and efficacy data.
A TEAE is any adverse event (AE), whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period).
Outcome measures
| Measure |
VIVITROL
n=38 Participants
Study drug was administered by intramuscular (IM) injection once monthly for 24 months.
|
|---|---|
|
Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study.
|
37 participants
|
Adverse Events
Medisorb Naltrexone 380 mg (VIVITROL)
Serious events: 2 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Medisorb Naltrexone 380 mg (VIVITROL)
n=38 participants at risk
Study drug was administered by intramuscular (IM) injection once monthly for 24 months.
|
|---|---|
|
Injury, poisoning and procedural complications
Head Injury
|
2.6%
1/38 • Number of events 1
|
|
Psychiatric disorders
Suicide Attempt
|
2.6%
1/38 • Number of events 1
|
Other adverse events
| Measure |
Medisorb Naltrexone 380 mg (VIVITROL)
n=38 participants at risk
Study drug was administered by intramuscular (IM) injection once monthly for 24 months.
|
|---|---|
|
General disorders
Injection site pain
|
36.8%
14/38 • Number of events 25
|
|
General disorders
Fatigue
|
10.5%
4/38 • Number of events 4
|
|
General disorders
Injection site induration
|
7.9%
3/38 • Number of events 5
|
|
General disorders
Injection site mass
|
7.9%
3/38 • Number of events 6
|
|
General disorders
Injection site nodule
|
7.9%
3/38 • Number of events 3
|
|
General disorders
Irritability
|
7.9%
3/38 • Number of events 3
|
|
General disorders
Chest pain
|
5.3%
2/38 • Number of events 2
|
|
General disorders
Discomfort
|
5.3%
2/38 • Number of events 3
|
|
General disorders
Oedema peripheral
|
5.3%
2/38 • Number of events 3
|
|
General disorders
Pyrexia
|
5.3%
2/38 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
42.1%
16/38 • Number of events 37
|
|
Gastrointestinal disorders
Diarrhoea
|
13.2%
5/38 • Number of events 11
|
|
Gastrointestinal disorders
Vomiting
|
13.2%
5/38 • Number of events 7
|
|
Gastrointestinal disorders
Toothache
|
7.9%
3/38 • Number of events 6
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.3%
2/38 • Number of events 6
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.3%
2/38 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
5.3%
2/38 • Number of events 3
|
|
Gastrointestinal disorders
Dyspepsia
|
5.3%
2/38 • Number of events 2
|
|
Psychiatric disorders
Anxiety
|
28.9%
11/38 • Number of events 16
|
|
Psychiatric disorders
Depression
|
13.2%
5/38 • Number of events 5
|
|
Psychiatric disorders
Insomnia
|
7.9%
3/38 • Number of events 5
|
|
Psychiatric disorders
Attention deficit/hyperactivity disorder
|
5.3%
2/38 • Number of events 2
|
|
Infections and infestations
Upper respiratory tract infection
|
21.1%
8/38 • Number of events 9
|
|
Infections and infestations
Bronchitis
|
13.2%
5/38 • Number of events 6
|
|
Infections and infestations
Sinusitis
|
13.2%
5/38 • Number of events 6
|
|
Infections and infestations
Tooth abscess
|
7.9%
3/38 • Number of events 5
|
|
Infections and infestations
Urinary tract infection
|
7.9%
3/38 • Number of events 3
|
|
Infections and infestations
Influenza
|
5.3%
2/38 • Number of events 3
|
|
Nervous system disorders
Headache
|
26.3%
10/38 • Number of events 12
|
|
Nervous system disorders
Dizziness
|
15.8%
6/38 • Number of events 6
|
|
Nervous system disorders
Amnesia
|
5.3%
2/38 • Number of events 2
|
|
Nervous system disorders
Disturbance in attention
|
5.3%
2/38 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
18.4%
7/38 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.3%
2/38 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.3%
2/38 • Number of events 2
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.5%
4/38 • Number of events 8
|
|
Metabolism and nutrition disorders
Increased appetite
|
5.3%
2/38 • Number of events 2
|
|
Injury, poisoning and procedural complications
Contusion
|
7.9%
3/38 • Number of events 6
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
5.3%
2/38 • Number of events 2
|
|
Injury, poisoning and procedural complications
Muscle strain
|
5.3%
2/38 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.9%
3/38 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.3%
2/38 • Number of events 2
|
|
Vascular disorders
Hypertension
|
5.3%
2/38 • Number of events 2
|
|
Immune system disorders
Seasonal allergy
|
5.3%
2/38 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A copy of such disclosure must be given to Alkermes for review at least sixty (60) days prior to submission for publication, presentation or delivery to any other party. Revisions to such disclosure will be negotiated in good faith by the Institution, Principal Investigator and Alkermes. Expedited reviews for abstracts or poster presentations may be arranged if mutually agreeable to Alkermes and the Institution.
- Publication restrictions are in place
Restriction type: OTHER