TraumaPhase 2TRAUMA_HELPNCT01007084
TRAUMA HELP: Healing and Analgesia With Propranolol
A Phase 2 study testing Propranolol, Propranolol ER and Sugar pills in people with Trauma, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Trauma
- What is being tested?
- Propranolol, Propranolol ER and Sugar pills
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Jul 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- at least one fracture
- ages 18-60 yrs
- pain score >= 4
- speak and read English
Who cannot join
- gunshot, stab wound, or assault
- paraplegia/quadriplegia
- pregnancy
- psychotic, suicidal, or homicidal
- hepatic, kidney failure
- clinically unstable or intubated at time of recruitment
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina Trauma Center
Chapel Hill, North Carolina, 27599
About this study
Official title: Phase IIB Study: TRAUMA HELP: Healing and Analgesia With Propranolol
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.
Read the 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.
- Conditions
- Trauma
- Being tested
- Propranolol, Propranolol ER, Sugar pills
- Keywords
- pain, trauma, propranolol
- Medical subject headings
- Wounds and Injuries, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropranololDrug
Also called Inderal, Innopran
40 mg
Propranolol ERDrug
Also called Inderal, Innopran
120 mg twice per day
Sugar pillsDrug
Also called Placebo
sugar pill
| Study group | Role | What they receive |
|---|---|---|
| Propranolol | Experimental | Not described Receives: Drug: Propranolol; Drug: Propranolol ER |
| Sugar pill | Placebo comparator | Not described Receives: Drug: Sugar pills |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily average pain score (0-10 numeric rating pain score recorded daily from patient) after study drug initiation.
Measured: Study days 1, 3, 5, 7, 10, 13, 17, and 19
Secondary outcomes (2)
Sleep quality
Measured: MOS Sleep Scale
Anxiety symptoms
Measured: 7 days, 6 weeks, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionJul 2010
- Study completionJul 2010
Why it stopped: Lack of eligible patient recruits/feasibility considerations.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel McLean, MD, University of North Carolina, Chapel Hill
- Investigators
- Samuel M McLean, MD MPH, Principal investigator, UNC Chapel Hill School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01007084
- Sponsor's protocol ID
- 09-1391
- Acronym
- TRAUMA_HELP
- Status last verified
- Dec 2011
- First submitted
- 2 Nov 2009
- Last updated
- 8 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIB Study: TRAUMA HELP: Healing and Analgesia With Propranolol
- ClinicalTrials.gov ID
- NCT01007084
- Acronym / sponsor ID
- TRAUMA_HELP / 09-1391
- Conditions
- Trauma
- Keywords
- pain, trauma, propranolol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of eligible patient recruits/feasibility considerations.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 3 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propranolol | Experimental | Drug: Propranolol, Drug: Propranolol ER |
| Sugar pill | Placebo comparator | Drug: Sugar pills |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- at least one fracture
- ages 18-60 yrs
- pain score >= 4
- speak and read English
Key exclusion criteria (14 listed)
- gunshot, stab wound, or assault
- paraplegia/quadriplegia
- pregnancy
- psychotic, suicidal, or homicidal
- hepatic, kidney failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropranololAlso: Inderal, Innopran40 mg | Drug | Propranolol |
| Propranolol ERAlso: Inderal, Innopran120 mg twice per day | Drug | Propranolol |
| Sugar pillsAlso: Placebosugar pill | Drug | Sugar pill |
Primary outcome
Daily average pain score (0-10 numeric rating pain score recorded daily from patient) after study drug initiation.
Time frame: Study days 1, 3, 5, 7, 10, 13, 17, and 19
2 secondary outcomes
Sleep quality
Time frame: MOS Sleep Scale
Anxiety symptoms
Time frame: 7 days, 6 weeks, 3 months, 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel M McLean, MD MPH principal investigator
UNC Chapel Hill School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Propranolol, Propranolol ER and Sugar pills in people with Trauma, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily average pain score (0-10 numeric rating pain score recorded daily from patient) after study drug initiation. (time frame: Study days 1, 3, 5, 7, 10, 13, 17, and 19). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2011.