Safety and Tolerability of Buprenorphine/Naloxone Film Strips

This study has been completed.

Study NCT00640835 Information provided by Reckitt Benckiser Pharmaceuticals, Inc

First Received on March 14, 2008. Last Updated on September 30, 2010 History of Changes

Results First Received: September 30, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Opioid-Related Disorders
Intervention:	Drug: Buprenorphine/naloxone Film Strip

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patient enrollment commenced 02/28/08 and was completed 04/15/08. All sites were medical clinics.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were required to be on a stabilized dose of buprenorphine and naloxone for at least 30 days prior to study drug administration, either during the screening period, or as part of routine medical treatment during the previous 30 days.

Reporting Groups

	Description
Buprenorphine/Naloxone Film Strip Administered Sublingually	No text entered.
Buprenorphine/Naloxone Film Strip Administered Buccally	No text entered.

Participant Flow: Overall Study

	Buprenorphine/Naloxone Film Strip Administered Sublingually	Buprenorphine/Naloxone Film Strip Administered Buccally
STARTED	194	188
COMPLETED	118	131
NOT COMPLETED	76	57
Adverse Event	5	3
Withdrawal by Subject	12	14
Physician Decision	10	14
Sponsor's Decision	11	7
Protocol Violation	2	2
Lost to Follow-up	17	13
Other Reason	19	4

Baseline Characteristics

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Reporting Groups

	Description
Buprenorphine/Naloxone Film Strip Administered Sublingually	No text entered.
Buprenorphine/Naloxone Film Strip Administered Buccally	No text entered.

Baseline Measures

	Buprenorphine/Naloxone Film Strip Administered Sublingually	Buprenorphine/Naloxone Film Strip Administered Buccally	Total
Number of Participants [units: participants]	194	188	382
Age [units: years] Mean ± Standard Deviation	36.1 ± 10.19	36.7 ± 10.09	36.4 ± 10.14
Gender [units: participants]
Female	70	72	142
Male	124	116	240
Ethnicity (NIH/OMB) [units: Participants]
Hispanic or Latino	0	0	0
Not Hispanic or Latino	194	188	382
Unknown or Not Reported	0	0	0
Race (NIH/OMB) [units: Participants]
American Indian or Alaska Native	0	0	0
Asian	1	0	1
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	1	1	2
White	192	187	379
More than one race	0	0	0
Unknown or Not Reported	0	0	0
Region of Enrollment [units: participants]
United States	194	188	382
Age ^[1] [units: Participants]
<21	4	0	4
21 - 35	102	99	201
36 - 50	71	67	138
>50	17	22	39
Severity Grading of Oral Mucosa ^[2] [units: Participants]
Grade 0	192	185	377
Grade 1	2	1	3
Grade 2	0	1	1
Grade 3	0	1	1

[1]	The age categories used for this study were slightly different than the standard values and are reflected as reported in the study.
[2]	Safety and tolerability were evaluated at baseline by oral cavity examination. Oral mucosa was graded as follows: Grade 0: Normal mucosa Grade 1: Localized mucosal erythema and/or irritation without ulceration Grade 2: Erythema and/or irritation and induration without ulceration Grade 3: Ulceration, with or without any other combination of signs

[1]

The age categories used for this study were slightly different than the standard values and are reflected as reported in the study.

[2]

Safety and tolerability were evaluated at baseline by oral cavity examination. Oral mucosa was graded as follows:

Grade 0: Normal mucosa Grade 1: Localized mucosal erythema and/or irritation without ulceration Grade 2: Erythema and/or irritation and induration without ulceration Grade 3: Ulceration, with or without any other combination of signs

Outcome Measures

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1. Primary:

Number of Subjects With Treatment-emergent Adverse Events Associated With the Oral Cavity. [ Time Frame: 12 weeks ]

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2. Primary:

Number of Subjects With Mild, Moderate or Severe Treatment-emergent Adverse Events Associated With the Oral Cavity [ Time Frame: 12 weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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: Proposed publications shall be submitted to Sponsor 30 days prior to submission for publication, and may be withheld for an additional period, up to 90 days, to allow Sponsor to file patent applications. If a multi-center publication isn't submitted for publication within 12 months of the conclusion of the Study at all sites, or is published in a shorter period, the results from the institution's site may be published individually.

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: Rolley E. Johnson, PharmD, Vice President, Clinical, Scientific and Regulatory Affairs
Organization: Reckitt Benckiser Pharmaceuticals, Inc.
phone: 804-379-1090 ext 7089
e-mail: ed.johnson@reckittbenckiser.com

No publications provided

Responsible Party:	Rolley E. Johnson, Pharm.D./Vice-President, Clinical, Scientific & Regulatory Affairs, Reckitt Benckiser Pharmaceuticals Inc
ClinicalTrials.gov Identifier:	NCT00640835 History of Changes
Other Study ID Numbers:	RB-US-07-0001
Study First Received:	March 14, 2008
Results First Received:	September 30, 2010
Last Updated:	September 30, 2010
Health Authority:	United States: Food and Drug Administration