Study of BEMA™ Buprenorphine in the Treatment of Dental Pain

This study has been completed.

Sponsor:

Information provided by:

BioDelivery Sciences International

ClinicalTrials.gov Identifier:

NCT00941304

First received: July 15, 2009

Last updated: November 24, 2009

Last verified: November 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

July 15, 2009

Last Updated Date

November 24, 2009

Start Date ^ICMJE

July 2009

Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Sum of Pain Intensity Differences (SPID) [ Time Frame: 8 hours ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00941304 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study of BEMA™ Buprenorphine in the Treatment of Dental Pain

Official Title ^ICMJE

A Double-Blind, Double-Dummy, Placebo- and Active Controlled Evaluation of the Efficacy, Safety and Tolerability of BEMA™ Buprenorphine in the Treatment of Pain Associated With Third Molar Extraction

Brief Summary

The purpose of this study is to assess the activity of BEMA™ Buprenorphine in the treatment of dental pain.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Dental Pain

Intervention ^ICMJE

Drug: oxycodone
oral dose of standard opioid
Drug: BEMA™ Buprenorphine
Different oral transmucosal (inside of cheek) doses of experimental study drug
Drug: Placebo
Doses that look like the study drugs without active drug

Study Arm (s)

Active Comparator: Standard Opioid
Intervention: Drug: oxycodone
Experimental: High Dose BEMA™ Buprenorphine
Intervention: Drug: BEMA™ Buprenorphine
Experimental: Medium Dose BEMA™ Buprenorphine
Intervention: Drug: BEMA™ Buprenorphine
Experimental: Low Dose BEMA™ Buprenorphine
Intervention: Drug: BEMA™ Buprenorphine
Placebo Comparator: Placebo
Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

150

Completion Date

November 2009

Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

extraction of 2 or more third molars, at least 1 of which must be fully or partially impacted in mandibular bone
males or non-pregnant females, aged 18 to 45 years
good general health and capable of providing informed consent

Exclusion Criteria:

history of substance abuse or dependence
positive urine toxicology screen or alcohol breath test
history of hypersensitivity to or allergy to any study drug
donation of blood within prior 30 days
use of analgesics, caffeine, sedatives, antidepressants, anticoagulant or antiplatelet agents

Gender

Both

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00941304

Other Study ID Numbers ^ICMJE

BUP-201

Has Data Monitoring Committee

Responsible Party

David Blum, MD, BioDelivery Sciences International

Study Sponsor ^ICMJE

BioDelivery Sciences International

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

David Blum, MD

BioDelivery Sciences International

Information Provided By

BioDelivery Sciences International

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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