ALK21-006EXT: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol- or Opioid-dependent Adults (Extension of Study ALK21-006 [NCT01218997])

This study has been terminated.

(Business decision)

Sponsor:

Information provided by:

Alkermes

ClinicalTrials.gov Identifier:

NCT00156936

First received: September 7, 2005

Last updated: November 5, 2010

Last verified: November 2010

History of Changes

Results First Received: October 8, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Alcoholism Opiate Dependence
Interventions:	Drug: Medisorb naltrexone 380 mg Drug: Oral naltrexone to Medisorb naltrexone 380 mg

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment was conducted at 17 clinical trial study centers in the United States.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Investigators ensured subjects were opioid-free (ie, had opioid-free urine screening results) prior to initiation of study therapy. For subjects diagnosed with opioid dependence or in whom clinically significant opioid use was suspected, a naloxone challenge test was performed.

Reporting Groups

	Description
Medisorb Naltrexone 380 mg (VIVITROL)	Subjects in this dosing group received VIVITROL (Medisorb naltrexone 380 mg) via intramuscular (IM) injection once every 4 weeks throughout the base study and continued on the same regimen throughout this extension.
Oral Naltrexone to Medisorb Naltrexone 380 mg (VIVITROL)	Subjects in this dosing group switched from oral naltrexone 50 mg daily in the base study to receive VIVITROL (Medisorb naltrexone 380) mg via IM injection once every 4 weeks in this extension study.

Participant Flow: Overall Study

	Medisorb Naltrexone 380 mg (VIVITROL)	Oral Naltrexone to Medisorb Naltrexone 380 mg (VIVITROL)
STARTED	92	16
COMPLETED	20	5
NOT COMPLETED	72	11

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Medisorb Naltrexone 380 mg (VIVITROL)	Subjects in this dosing group received VIVITROL (Medisorb naltrexone 380 mg) via intramuscular (IM) injection once every 4 weeks throughout the base study and continued on the same regimen throughout this extension.
Oral Naltrexone to Medisorb Naltrexone 380 mg (VIVITROL)	Subjects in this dosing group switched from oral naltrexone 50 mg daily in the base study to receive VIVITROL (Medisorb naltrexone 380) mg via IM injection once every 4 weeks in this extension study.
Total	Total of all reporting groups

Baseline Measures

	Medisorb Naltrexone 380 mg (VIVITROL)	Oral Naltrexone to Medisorb Naltrexone 380 mg (VIVITROL)	Total
Number of Participants [units: participants]	92	16	108
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	92	16	108
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	42.3 ± 10.0	45.3 ± 11.5	42.7 ± 10.3
Gender [units: participants]
Female	30	5	35
Male	62	11	73
Region of Enrollment [units: participants]
United States	92	16	108

Outcome Measures

1. Primary:

Number of Subjects Who Reported at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study. [ Time Frame: Up to 3 years ]

Show Outcome Measure 1

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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 but less than or equal to 90 days from the time submitted to the sponsor for review. Revisions will be negotiated in good faith. For a multicenter study, the institution/PI agree to publish/publicly present the results together with the other sites unless the sponsor grants written permission in advance.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Bernard L. Silverman / VP, Clinical Development
Organization: Alkermes, Inc.
phone: 781-609-6000
e-mail: bernard.silverman@alkermes.com

No publications provided

Responsible Party:	Bernard L. Silverman, MD / VP, Clinical Development, Alkermes, Inc.
ClinicalTrials.gov Identifier:	NCT00156936 History of Changes
Other Study ID Numbers:	ALK21-006EXT
Study First Received:	September 7, 2005
Results First Received:	October 8, 2010
Last Updated:	November 5, 2010
Health Authority:	United States: Food and Drug Administration

To Top