TRAUMA HELP: Healing and Analgesia With Propranolol | NCT01007084

Studies
TRAUMA HELP: Healing and Analgesia With Propranolol

NCT01007084

Sponsor

University of North Carolina, Chapel Hill

Status

Withdrawn

Last Update Posted

Dec 8, 2011Estimated

Enrollment

0Actual

Phase

Phase 2

Conditions

Trauma

Interventions

Propranolol
Propranolol ER
Sugar pills

Countries

United States

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 2011

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of eligible patient recruits/feasibility considerations.

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Jul 2010Actual

Completion Date

Jul 2010Actual

First Submitted Date

Nov 2, 2009

First Submission Date that Met QC Criteria

Nov 2, 2009

First Posted Date

Nov 3, 2009Estimated

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 7, 2011

Last Update Posted Date

Dec 8, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Samuel McLean, MD, Principle Investigator, University of North Carolina, Chapel HillPrincipal Investigator

Lead Sponsor

University of North Carolina, Chapel HillOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 propranolol can decrease pain symptoms in a common subset of patients admitted to a trauma center after injury.

Detailed Description

The main purpose of this pilot study is to investigate Propranolol's utility in the trauma population. Specifically, to see if it reduces pain scores post-injury.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Propranolol	Experimental		Drug: Propranolol Drug: Propranolol ER
Sugar pill	Placebo Comparator		Drug: Sugar pills

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Propranolol	Drug	40 mg	Propranolol	Inderal Innopran

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Daily average pain score (0-10 numeric rating pain score recorded daily from patient) after study drug initiation.		Study days 1, 3, 5, 7, 10, 13, 17, and 19

Secondary Outcomes

Measure	Description	Time Frame
Sleep quality		MOS Sleep Scale
Anxiety symptoms		7 days, 6 weeks, 3 months, 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

at least one fracture
ages 18-60 yrs
pain score >= 4
speak and read English

Exclusion Criteria:

gunshot, stab wound, or assault
paraplegia/quadriplegia
pregnancy
psychotic, suicidal, or homicidal
hepatic, kidney failure
clinically unstable or intubated at time of recruitment
hyperthyroidism
propranolol use within the last 6 months
significant bradycardia
cancer (except basal cell)
peripheral vascular disease
heart block > 1 degree
breastfeeding
congestive heart failure

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Samuel M McLean, MD MPH	UNC Chapel Hill School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of North Carolina Trauma Center		Chapel Hill	North Carolina	27599	United States

Condition Browse Module

MeSH Terms

ID	Term
D014947	Wounds and Injuries
D010146	Pain

Ancestor Terms

ID	Term
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
D011433	Propranolol

Ancestor Terms

ID	Term
D050198	Phenoxypropanolamines
D011412	Propanolamines
D000605	Amino Alcohols
D000438	Alcohols

Browse Leaves

Not provided

Browse Branches

Not provided