Study Stopped
Lack of eligible patient recruits/feasibility considerations.
TRAUMA HELP: Healing and Analgesia With Propranolol
TRAUMA_HELP
Phase IIB Study: TRAUMA HELP: Healing and Analgesia With Propranolol
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2009
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 2, 2009
CompletedFirst Posted
Study publicly available on registry
November 3, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedDecember 8, 2011
December 1, 2011
9 months
November 2, 2009
December 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 (2)
Sleep quality
MOS Sleep Scale
Anxiety symptoms
7 days, 6 weeks, 3 months, 6 months
Study Arms (2)
Propranolol
EXPERIMENTALSugar pill
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- at least one fracture
- ages 18-60 yrs
- pain score \>= 4
- speak and read English
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of North Carolina Trauma Center
Chapel Hill, North Carolina, 27599, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Samuel M McLean, MD MPH
UNC Chapel Hill School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
November 2, 2009
First Posted
November 3, 2009
Study Start
October 1, 2009
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
December 8, 2011
Record last verified: 2011-12