Trial · NCT01218997
ALK21-006: Long-Term Study of Medisorb® Naltrexone (VIVITROL®)
NCT01218997, Phase 3, Completed, Alkermes, Inc.; results first posted 2010-12-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. ALK21-006: Long-Term Study of Medisorb® Naltrexone (VIVITROL®). Trials, record NCT01218997. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01218997
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ALK21-006: Long-Term Study of Medisorb® Naltrexone (VIVITROL®)
- NCT number
- NCT01218997
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 436 participants, actual
- Lead sponsor
- Alkermes, Inc.
- Conditions
- Alcoholism
- Interventions
- Medisorb naltrexone 380 mg, Oral naltrexone 50 mg
- First posted
- 2010-10-13
- Last updated
- 2011-01-04
- Results first posted
- 2010-12-13
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study | up to 1 year | 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. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study | up to 1 year | All subjects who received at least 1 dose of study drug are included in the safety population. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study | Medisorb Naltrexone 380 mg (VIVITROL) | 336 | Participants | ||
| Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study | Oral Naltrexone 50 mg | 53 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Medisorb Naltrexone 380 mg (VIVITROL) | 371 | |
| Overall Study | STARTED | Oral Naltrexone 50 mg | 65 | |
| Overall Study | COMPLETED | Medisorb Naltrexone 380 mg (VIVITROL) | 126 | |
| Overall Study | COMPLETED | Oral Naltrexone 50 mg | 24 | |
| Overall Study | NOT COMPLETED | Medisorb Naltrexone 380 mg (VIVITROL) | 245 | |
| Overall Study | NOT COMPLETED | Oral Naltrexone 50 mg | 41 |
Source ClinicalTrials.gov
Adverse events132
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Medisorb Naltrexone 380 mg (VIVITROL) | 75 | 371 | |
| other | Nausea | Gastrointestinal disorders | Oral Naltrexone 50 mg | 19 | 65 | |
| other | Vomiting NOS | Gastrointestinal disorders | Medisorb Naltrexone 380 mg (VIVITROL) | 32 | 371 | |
| other | Vomiting NOS | Gastrointestinal disorders | Oral Naltrexone 50 mg | 7 | 65 | |
| other | Diarrhoea NOS | Gastrointestinal disorders | Medisorb Naltrexone 380 mg (VIVITROL) | 18 | 371 | |
| other | Diarrhoea NOS | Gastrointestinal disorders | Oral Naltrexone 50 mg | 6 | 65 | |
| other | Abdominal pain NOS | Gastrointestinal disorders | Medisorb Naltrexone 380 mg (VIVITROL) | 19 | 371 | |
| other | Abdominal pain NOS | Gastrointestinal disorders | Oral Naltrexone 50 mg | 3 | 65 | |
| other | Dyspepsia | Gastrointestinal disorders | Medisorb Naltrexone 380 mg (VIVITROL) | 10 | 371 | |
| other | Dyspepsia | Gastrointestinal disorders | Oral Naltrexone 50 mg | 5 | 65 |
1 to 10 of 132Source ClinicalTrials.gov
See all 132 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Medisorb Naltrexone 380 mg (VIVITROL) | ||
| Total, all-cause mortality | Oral Naltrexone 50 mg | ||
| Total, other adverse events | Medisorb Naltrexone 380 mg (VIVITROL) | 336 | 371 |
| Total, other adverse events | Oral Naltrexone 50 mg | 53 | 65 |
| Total, serious adverse events | Medisorb Naltrexone 380 mg (VIVITROL) | 49 | 371 |
| Total, serious adverse events | Oral Naltrexone 50 mg | 5 | 65 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Medisorb Naltrexone 380 mg (VIVITROL) vs Oral Naltrexone 50 mg: Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study | Trial comparisons |
| Medisorb Naltrexone 380 mg (VIVITROL) vs Oral Naltrexone 50 mg: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01218997
GET https://conductscience.org/api/trials/v1/NCT01218997/events?page=2