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ALK21-003EXT: An Extension of Study ALK21-003 (NCT01218958) to Test the Long-term Safety of Medisorb® Naltrexone (VIVITROL®)

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ClinicalTrials.gov Identifier: NCT01218971
Recruitment Status : Completed
First Posted : October 13, 2010
Results First Posted : December 8, 2010
Last Update Posted : December 24, 2010
Sponsor:
Information provided by:
Alkermes, Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Alcohol Dependence
Interventions Drug: Medisorb naltrexone 190 mg
Drug: Medisorb naltrexone 380 mg
Enrollment 332

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Medisorb Naltrexone 380 mg Medisorb Naltrexone 190 mg
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Overall Study
Started 175 157
Completed 71 77
Not Completed 104 80
Arm/Group Title Medisorb Naltrexone 380 mg Medisorb Naltrexone 190 mg Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 175 157 332
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 175 participants 157 participants 332 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
168
  96.0%
149
  94.9%
317
  95.5%
>=65 years
7
   4.0%
8
   5.1%
15
   4.5%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 175 participants 157 participants 332 participants
45.5  (9.6) 47.4  (10.5) 46.4  (10.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 175 participants 157 participants 332 participants
Female
62
  35.4%
53
  33.8%
115
  34.6%
Male
113
  64.6%
104
  66.2%
217
  65.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 175 participants 157 participants 332 participants
175 157 332
1.Primary Outcome
Title Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While in Study
Hide Description A TEAE is any adverse event, 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).
Time Frame Up to 48 weeks (13 injections), not including base study
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug are included in the safety population.
Arm/Group Title Medisorb Naltrexone 380 mg Medisorb Naltrexone 190 mg
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 175 157
Measure Type: Number
Unit of Measure: Participants
143 130
Time Frame 1 year (Baseline to Week 52)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Medisorb Naltrexone 380mg--Combined Medisorb Naltrexone 190mg--Combined Placebo to 380mg 380mg to 380mg Placebo to 190mg 190mg to 190mg
Hide Arm/Group Description Includes all participants who received Medisorb naltrexone 380mg in this extension study. Study drug was administered via intramuscular (IM) injection once every 4 weeks. Includes all participants who received Medisorb naltrexone 190mg in this extension study. Study drug was administered via intramuscular (IM) injection once every 4 weeks. Includes participants who received placebo in the base study but switched to Medisorb naltrexone 380mg in this extension. Study drug was administered via intramuscular (IM) injection once every 4 weeks. Includes participants who received Medisorb naltrexone 380mg in the base study and continued with the same dose strength in this extension. Study drug was administered via intramuscular (IM) injection once every 4 weeks. Includes participants who received placebo in the base study but switched to Medisorb naltrexone 190mg in this extension. Study drug was administered via intramuscular (IM) injection once every 4 weeks. includes participants who received Medisorb naltrexone 190mg in the base study and continued with the same dose strength in this extension. Study drug was administered via intramuscular (IM) injection once every 4 weeks.
All-Cause Mortality
Medisorb Naltrexone 380mg--Combined Medisorb Naltrexone 190mg--Combined Placebo to 380mg 380mg to 380mg Placebo to 190mg 190mg to 190mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Medisorb Naltrexone 380mg--Combined Medisorb Naltrexone 190mg--Combined Placebo to 380mg 380mg to 380mg Placebo to 190mg 190mg to 190mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/175 (3.43%)   12/157 (7.64%)   2/60 (3.33%)   4/115 (3.48%)   2/55 (3.64%)   10/102 (9.80%) 
Cardiac disorders             
Angina pectoris  1  0/175 (0.00%)  1/157 (0.64%)  0/60 (0.00%)  0/115 (0.00%)  0/55 (0.00%)  1/102 (0.98%) 
Cardiac failure congestive  1  1/175 (0.57%)  0/157 (0.00%)  0/60 (0.00%)  1/115 (0.87%)  0/55 (0.00%)  0/102 (0.00%) 
Gastrointestinal disorders             
Abdominal pain NOS  1  1/175 (0.57%)  0/157 (0.00%)  0/60 (0.00%)  1/115 (0.87%)  0/55 (0.00%)  0/102 (0.00%) 
Abdominal pain upper  1  1/175 (0.57%)  0/157 (0.00%)  0/60 (0.00%)  1/115 (0.87%)  0/55 (0.00%)  0/102 (0.00%) 
Colitis ischaemic  1  0/175 (0.00%)  1/157 (0.64%)  0/60 (0.00%)  0/115 (0.00%)  0/55 (0.00%)  1/102 (0.98%) 
General disorders             
Chest pain  1  0/175 (0.00%)  1/157 (0.64%)  0/60 (0.00%)  0/115 (0.00%)  0/55 (0.00%)  1/102 (0.98%) 
Hepatobiliary disorders             
Cholecystitis acute NOS  1  0/175 (0.00%)  1/157 (0.64%)  0/60 (0.00%)  0/115 (0.00%)  0/55 (0.00%)  1/102 (0.98%) 
Cholelithiasis  1  0/175 (0.00%)  1/157 (0.64%)  0/60 (0.00%)  0/115 (0.00%)  0/55 (0.00%)  1/102 (0.98%) 
Hepatitis acute  1  0/175 (0.00%)  1/157 (0.64%)  0/60 (0.00%)  0/115 (0.00%)  0/55 (0.00%)  1/102 (0.98%) 
Infections and infestations             
Pneumonia NOS  1  0/175 (0.00%)  1/157 (0.64%)  0/60 (0.00%)  0/115 (0.00%)  0/55 (0.00%)  1/102 (0.98%) 
Injury, poisoning and procedural complications             
Limb injury NOS  1  0/175 (0.00%)  1/157 (0.64%)  0/60 (0.00%)  0/115 (0.00%)  0/55 (0.00%)  1/102 (0.98%) 
Road traffic accident  1  0/175 (0.00%)  1/157 (0.64%)  0/60 (0.00%)  0/115 (0.00%)  0/55 (0.00%)  1/102 (0.98%) 
Metabolism and nutrition disorders             
Dehydration  1  0/175 (0.00%)  1/157 (0.64%)  0/60 (0.00%)  0/115 (0.00%)  1/55 (1.82%)  0/102 (0.00%) 
Musculoskeletal and connective tissue disorders             
Intervertebral disc degeneration NOS  1  1/175 (0.57%)  0/157 (0.00%)  1/60 (1.67%)  0/115 (0.00%)  0/55 (0.00%)  0/102 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Pancreatic carcinoma NOS  1  1/175 (0.57%)  0/157 (0.00%)  0/60 (0.00%)  1/115 (0.87%)  0/55 (0.00%)  0/102 (0.00%) 
Psychiatric disorders             
Alcoholism  1  0/175 (0.00%)  3/157 (1.91%)  0/60 (0.00%)  0/115 (0.00%)  2/55 (3.64%)  1/102 (0.98%) 
Suicidal ideation  1  0/175 (0.00%)  1/157 (0.64%)  0/60 (0.00%)  0/115 (0.00%)  0/55 (0.00%)  1/102 (0.98%) 
Social circumstances             
Drug abuser NOS  1  1/175 (0.57%)  0/157 (0.00%)  1/60 (1.67%)  0/115 (0.00%)  0/55 (0.00%)  0/102 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (4.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Medisorb Naltrexone 380mg--Combined Medisorb Naltrexone 190mg--Combined Placebo to 380mg 380mg to 380mg Placebo to 190mg 190mg to 190mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   143/175 (81.71%)   130/157 (82.80%)   51/60 (85.00%)   92/115 (80.00%)   46/55 (83.64%)   84/102 (82.35%) 
Gastrointestinal disorders             
Nausea  1  17/175 (9.71%)  14/157 (8.92%)  6/60 (10.00%)  11/115 (9.57%)  10/55 (18.18%)  4/102 (3.92%) 
Vomiting NOS  1  5/175 (2.86%)  8/157 (5.10%)  3/60 (5.00%)  2/115 (1.74%)  1/55 (1.82%)  7/102 (6.86%) 
General disorders             
Injection site induration  1  11/175 (6.29%)  5/157 (3.18%)  9/60 (15.00%)  2/115 (1.74%)  4/55 (7.27%)  1/102 (0.98%) 
Fatigue  1  15/175 (8.57%)  10/157 (6.37%)  8/60 (13.33%)  7/115 (6.09%)  5/55 (9.09%)  5/102 (4.90%) 
Injection site pain  1  10/175 (5.71%)  8/157 (5.10%)  4/60 (6.67%)  6/115 (5.22%)  6/55 (10.91%)  2/102 (1.96%) 
Influenza like illness  1  3/175 (1.71%)  12/157 (7.64%)  2/60 (3.33%)  1/115 (0.87%)  4/55 (7.27%)  8/102 (7.84%) 
Immune system disorders             
Seasonal allergy  1  1/175 (0.57%)  4/157 (2.55%)  1/60 (1.67%)  0/115 (0.00%)  3/55 (5.45%)  1/102 (0.98%) 
Infections and infestations             
Nasopharyngitis  1  16/175 (9.14%)  21/157 (13.38%)  8/60 (13.33%)  8/115 (6.96%)  6/55 (10.91%)  15/102 (14.71%) 
Upper respiratory tract infection NOS  1  18/175 (10.29%)  18/157 (11.46%)  6/60 (10.00%)  12/115 (10.43%)  7/55 (12.73%)  11/102 (10.78%) 
Sinusitis NOS  1  7/175 (4.00%)  9/157 (5.73%)  5/60 (8.33%)  2/115 (1.74%)  4/55 (7.27%)  5/102 (4.90%) 
Influenza  1  11/175 (6.29%)  1/157 (0.64%)  4/60 (6.67%)  7/115 (6.09%)  0/55 (0.00%)  1/102 (0.98%) 
Bronchitis NOS  1  6/175 (3.43%)  3/157 (1.91%)  3/60 (5.00%)  3/115 (2.61%)  0/55 (0.00%)  3/102 (2.94%) 
Gastroenteritis viral NOS  1  7/175 (4.00%)  1/157 (0.64%)  1/60 (1.67%)  6/115 (5.22%)  0/55 (0.00%)  1/102 (0.98%) 
Injury, poisoning and procedural complications             
Back injury NOS  1  1/175 (0.57%)  3/157 (1.91%)  0/60 (0.00%)  1/115 (0.87%)  3/55 (5.45%)  0/102 (0.00%) 
Metabolism and nutrition disorders             
Appetite decreased NOS  1  4/175 (2.29%)  4/157 (2.55%)  2/60 (3.33%)  2/115 (1.74%)  4/55 (7.27%)  0/102 (0.00%) 
Musculoskeletal and connective tissue disorders             
Back pain  1  16/175 (9.14%)  9/157 (5.73%)  6/60 (10.00%)  10/115 (8.70%)  5/55 (9.09%)  4/102 (3.92%) 
Pain in limb  1  10/175 (5.71%)  5/157 (3.18%)  5/60 (8.33%)  5/115 (4.35%)  1/55 (1.82%)  4/102 (3.92%) 
Arthralgia  1  11/175 (6.29%)  9/157 (5.73%)  2/60 (3.33%)  9/115 (7.83%)  2/55 (3.64%)  7/102 (6.86%) 
Nervous system disorders             
Headache NOS  1  18/175 (10.29%)  20/157 (12.74%)  8/60 (13.33%)  10/115 (8.70%)  4/55 (7.27%)  16/102 (15.69%) 
Dizziness  1  4/175 (2.29%)  7/157 (4.46%)  1/60 (1.67%)  3/115 (2.61%)  4/55 (7.27%)  3/102 (2.94%) 
Psychiatric disorders             
Insomnia  1  11/175 (6.29%)  11/157 (7.01%)  4/60 (6.67%)  7/115 (6.09%)  4/55 (7.27%)  7/102 (6.86%) 
Depression  1  5/175 (2.86%)  15/157 (9.55%)  3/60 (5.00%)  2/115 (1.74%)  8/55 (14.55%)  7/102 (6.86%) 
Anxiety NEC  1  5/175 (2.86%)  4/157 (2.55%)  2/60 (3.33%)  3/115 (2.61%)  3/55 (5.45%)  1/102 (0.98%) 
Alcoholism  1  2/175 (1.14%)  5/157 (3.18%)  0/60 (0.00%)  2/115 (1.74%)  4/55 (7.27%)  1/102 (0.98%) 
Respiratory, thoracic and mediastinal disorders             
Nasal congestion  1  4/175 (2.29%)  3/157 (1.91%)  3/60 (5.00%)  1/115 (0.87%)  0/55 (0.00%)  3/102 (2.94%) 
Skin and subcutaneous tissue disorders             
Rash NOS  1  4/175 (2.29%)  4/157 (2.55%)  3/60 (5.00%)  1/115 (0.87%)  1/55 (1.82%)  3/102 (2.94%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (4.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Bernard L. Silverman, MD
Organization: Alkermes, Inc.
Phone: 781-609-6000
Responsible Party: Bernard Silverman, MD / Vice President, Clinical Development, Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT01218971     History of Changes
Other Study ID Numbers: ALK21-003-EXT
First Submitted: October 8, 2010
First Posted: October 13, 2010
Results First Submitted: November 8, 2010
Results First Posted: December 8, 2010
Last Update Posted: December 24, 2010