Trial Outcomes & Findings for ALK21-004: Single-dose Opiate Challenge of Medisorb® Naltrexone (VIVITROL®) in Adults Who Use Opioids (NCT NCT01218984)
NCT ID: NCT01218984
Last Updated: 2017-01-11
Results Overview
Photographs of subjects' pupils were measured horizontally and vertically, 15 minutes before the first hydromorphone dose and every 15 minutes after each hydromorphone/placebo for hydromorphone dose, for up to 1 hour. Size was the product of vertical and horizontal measures. The slope, determined by linear regression, was used as a summary measure of the dose-response relationship between the hydromorphone dose and pupil size. The steeper the slope, the greater the hydromorphone effect. A slope of zero indicated no evidence of a hydromorphone effect.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
4 weeks (Baseline to Day 28)
Results posted on
2017-01-11
Participant Flow
Participant milestones
| Measure |
Medisorb Naltrexone 75 mg
Administered as a single gluteal intramuscular (IM) injection
|
Medisorb Naltrexone 150 mg
Administered as a single gluteal IM injection
|
Medisorb Naltrexone 300 mg
Administered as a single gluteal IM injection
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
8
|
10
|
|
Overall Study
COMPLETED
|
8
|
6
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ALK21-004: Single-dose Opiate Challenge of Medisorb® Naltrexone (VIVITROL®) in Adults Who Use Opioids
Baseline characteristics by cohort
| Measure |
Medisorb Naltrexone 75 mg
n=9 Participants
Administered as a single gluteal intramuscular (IM) injection
|
Medisorb Naltrexone 150 mg
n=8 Participants
Administered as a single gluteal IM injection
|
Medisorb Naltrexone 300 mg
n=10 Participants
Administered as a single gluteal IM injection
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
35.22 years
STANDARD_DEVIATION 9.28 • n=5 Participants
|
42.88 years
STANDARD_DEVIATION 4.70 • n=7 Participants
|
32.5 years
STANDARD_DEVIATION 8.02 • n=5 Participants
|
36.48 years
STANDARD_DEVIATION 8.60 • n=4 Participants
|
|
Gender
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Gender
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
10 participants
n=5 Participants
|
27 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 4 weeks (Baseline to Day 28)Population: Placebo hydromorphone challenge sessions were excluded from the analysis. Results for subjects who discontinued prior to Day 28 were not imputed.
Photographs of subjects' pupils were measured horizontally and vertically, 15 minutes before the first hydromorphone dose and every 15 minutes after each hydromorphone/placebo for hydromorphone dose, for up to 1 hour. Size was the product of vertical and horizontal measures. The slope, determined by linear regression, was used as a summary measure of the dose-response relationship between the hydromorphone dose and pupil size. The steeper the slope, the greater the hydromorphone effect. A slope of zero indicated no evidence of a hydromorphone effect.
Outcome measures
| Measure |
Medisorb Naltrexone 75 mg
n=6 Participants
Administered as a single gluteal intramuscular (IM) injection
|
Medisorb Naltrexone 150 mg
n=4 Participants
Administered as a single gluteal IM injection
|
Medisorb Naltrexone 300 mg
n=6 Participants
Administered as a single gluteal IM injection
|
|---|---|---|---|
|
Slope Change From Baseline for Pupil Size
|
-0.5540 cm(2)/hr
Standard Deviation 0.3473
|
-0.3607 cm(2)/hr
Standard Deviation 0.3998
|
-0.1410 cm(2)/hr
Standard Deviation 0.1745
|
Adverse Events
Medisorb Naltrexone 75 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Medisorb Naltrexone 150 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Medisorb Naltrexone 300 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Medisorb Naltrexone 75 mg
n=9 participants at risk
Administered as a single gluteal intramuscular (IM) injection
|
Medisorb Naltrexone 150 mg
n=8 participants at risk
Administered as a single gluteal IM injection
|
Medisorb Naltrexone 300 mg
n=10 participants at risk
Administered as a single gluteal IM injection
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.1%
1/9 • 56 Days
|
0.00%
0/8 • 56 Days
|
0.00%
0/10 • 56 Days
|
|
Gastrointestinal disorders
Anal fissure
|
11.1%
1/9 • 56 Days
|
0.00%
0/8 • 56 Days
|
0.00%
0/10 • 56 Days
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/9 • 56 Days
|
0.00%
0/8 • 56 Days
|
10.0%
1/10 • 56 Days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/9 • 56 Days
|
0.00%
0/8 • 56 Days
|
10.0%
1/10 • 56 Days
|
|
Gastrointestinal disorders
Toothache
|
11.1%
1/9 • 56 Days
|
0.00%
0/8 • 56 Days
|
0.00%
0/10 • 56 Days
|
|
General disorders
Application site rash
|
0.00%
0/9 • 56 Days
|
12.5%
1/8 • 56 Days
|
0.00%
0/10 • 56 Days
|
|
General disorders
Fatigue
|
0.00%
0/9 • 56 Days
|
12.5%
1/8 • 56 Days
|
10.0%
1/10 • 56 Days
|
|
General disorders
Infusion site pain
|
11.1%
1/9 • 56 Days
|
0.00%
0/8 • 56 Days
|
0.00%
0/10 • 56 Days
|
|
General disorders
Pain NOS
|
11.1%
1/9 • 56 Days
|
0.00%
0/8 • 56 Days
|
0.00%
0/10 • 56 Days
|
|
General disorders
Pyrexia
|
0.00%
0/9 • 56 Days
|
0.00%
0/8 • 56 Days
|
10.0%
1/10 • 56 Days
|
|
Infections and infestations
Hepatitis C
|
0.00%
0/9 • 56 Days
|
0.00%
0/8 • 56 Days
|
10.0%
1/10 • 56 Days
|
|
Infections and infestations
Influenza
|
11.1%
1/9 • 56 Days
|
0.00%
0/8 • 56 Days
|
0.00%
0/10 • 56 Days
|
|
Infections and infestations
Nasopharyngitis
|
11.1%
1/9 • 56 Days
|
0.00%
0/8 • 56 Days
|
10.0%
1/10 • 56 Days
|
|
Injury, poisoning and procedural complications
Chemical burns of eye
|
0.00%
0/9 • 56 Days
|
0.00%
0/8 • 56 Days
|
10.0%
1/10 • 56 Days
|
|
Injury, poisoning and procedural complications
Injury NOS
|
11.1%
1/9 • 56 Days
|
12.5%
1/8 • 56 Days
|
0.00%
0/10 • 56 Days
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/9 • 56 Days
|
12.5%
1/8 • 56 Days
|
0.00%
0/10 • 56 Days
|
|
Injury, poisoning and procedural complications
Limb injury NOS
|
0.00%
0/9 • 56 Days
|
12.5%
1/8 • 56 Days
|
0.00%
0/10 • 56 Days
|
|
Injury, poisoning and procedural complications
Mouth injury
|
0.00%
0/9 • 56 Days
|
0.00%
0/8 • 56 Days
|
10.0%
1/10 • 56 Days
|
|
Injury, poisoning and procedural complications
Tendon injury
|
11.1%
1/9 • 56 Days
|
0.00%
0/8 • 56 Days
|
0.00%
0/10 • 56 Days
|
|
Investigations
Blood in stool
|
0.00%
0/9 • 56 Days
|
0.00%
0/8 • 56 Days
|
10.0%
1/10 • 56 Days
|
|
Investigations
Heart rate increased
|
11.1%
1/9 • 56 Days
|
0.00%
0/8 • 56 Days
|
0.00%
0/10 • 56 Days
|
|
Investigations
Liver function tests NOS abnormal
|
0.00%
0/9 • 56 Days
|
0.00%
0/8 • 56 Days
|
10.0%
1/10 • 56 Days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/9 • 56 Days
|
0.00%
0/8 • 56 Days
|
10.0%
1/10 • 56 Days
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
11.1%
1/9 • 56 Days
|
0.00%
0/8 • 56 Days
|
0.00%
0/10 • 56 Days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/9 • 56 Days
|
12.5%
1/8 • 56 Days
|
0.00%
0/10 • 56 Days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/9 • 56 Days
|
0.00%
0/8 • 56 Days
|
10.0%
1/10 • 56 Days
|
|
Nervous system disorders
Headache NOS
|
11.1%
1/9 • 56 Days
|
12.5%
1/8 • 56 Days
|
10.0%
1/10 • 56 Days
|
|
Nervous system disorders
Somnolence
|
0.00%
0/9 • 56 Days
|
0.00%
0/8 • 56 Days
|
10.0%
1/10 • 56 Days
|
|
Nervous system disorders
Tremor
|
11.1%
1/9 • 56 Days
|
0.00%
0/8 • 56 Days
|
0.00%
0/10 • 56 Days
|
|
Psychiatric disorders
Factitious disorder NOS
|
0.00%
0/9 • 56 Days
|
0.00%
0/8 • 56 Days
|
10.0%
1/10 • 56 Days
|
|
Psychiatric disorders
Insomnia
|
11.1%
1/9 • 56 Days
|
0.00%
0/8 • 56 Days
|
10.0%
1/10 • 56 Days
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/9 • 56 Days
|
12.5%
1/8 • 56 Days
|
0.00%
0/10 • 56 Days
|
|
Reproductive system and breast disorders
Dysmennorhoea
|
11.1%
1/9 • 56 Days
|
0.00%
0/8 • 56 Days
|
0.00%
0/10 • 56 Days
|
|
Respiratory, thoracic and mediastinal disorders
Chest wall pain
|
0.00%
0/9 • 56 Days
|
0.00%
0/8 • 56 Days
|
10.0%
1/10 • 56 Days
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
11.1%
1/9 • 56 Days
|
0.00%
0/8 • 56 Days
|
0.00%
0/10 • 56 Days
|
|
Skin and subcutaneous tissue disorders
Contusion
|
0.00%
0/9 • 56 Days
|
12.5%
1/8 • 56 Days
|
0.00%
0/10 • 56 Days
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/9 • 56 Days
|
0.00%
0/8 • 56 Days
|
10.0%
1/10 • 56 Days
|
|
Skin and subcutaneous tissue disorders
Pruritis NOS
|
0.00%
0/9 • 56 Days
|
0.00%
0/8 • 56 Days
|
10.0%
1/10 • 56 Days
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
11.1%
1/9 • 56 Days
|
0.00%
0/8 • 56 Days
|
0.00%
0/10 • 56 Days
|
|
Skin and subcutaneous tissue disorders
Sweating increased
|
11.1%
1/9 • 56 Days
|
0.00%
0/8 • 56 Days
|
0.00%
0/10 • 56 Days
|
Additional Information
Bernard L. Silverman, VP, Clinical Development
Alkermes, Inc.
Phone: 781-609-6000
Email: [email protected]
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