Efficacy of Buprenorphine for Treatment of Acute Pain | NCT01298297

Studies
Efficacy of Buprenorphine for Treatment of Acute Pain

NCT01298297

Sponsor

Tehran University of Medical Sciences

Status

Completed

Last Update Posted

Dec 10, 2012Estimated

Enrollment

80Actual

Phase

Phase 4

Conditions

Acute Pain

Interventions

Buprenorphine
Morphine

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2010

Primary Completion Date

Mar 2011Actual

Completion Date

Mar 2011Actual

First Submitted Date

Feb 15, 2011

First Submission Date that Met QC Criteria

Feb 15, 2011

First Posted Date

Feb 17, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 6, 2012

Last Update Posted Date

Dec 10, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine whether sublingual buprenorphine is effective in the treatment of acute pain in adult patients with extremity bone fractures

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Buprenorphine + Placebo	Active Comparator		Drug: Buprenorphine
Morphine + Placebo	Placebo Comparator		Drug: Morphine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Buprenorphine	Drug	0.4 mg, SL (sublingual) Buprenorphine PLUS 5 ml Placebo IV (in the vein)	Buprenorphine + Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in pain severity/score		After 60 min

Secondary Outcomes

Measure	Description	Time Frame
Need for rescue analgesia		After 60 min
Occurrence of adverse events		During 60 min

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of extremity bone fracture Age>16 years Acute pain of score 3 or greater on numerical rating scale

Exclusion Criteria:

Long term use of opium or opioids/dependence Previous administration of analgesic Known sensitivity to opioids Pregnant women History of medical problems (liver, kidney, heart, hematologic)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Emergency Department, Imam Hospital		Tehran	Tehran Province		Iran

Condition Browse Module

MeSH Terms

ID	Term
D059787	Acute Pain
D000377	Agnosia

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002047	Buprenorphine
D009020	Morphine

Ancestor Terms

ID	Term
D009019	Morphinans
D053610	Opiate Alkaloids
D000470	Alkaloids
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided