ItchingNCT00137202
Post Burn Pruritus Study in Patients Undergoing Wound Healing
A study testing Ondansetron (Zofran) and Diphenhydramine (Benadryl) in people with Itching, run by United States Army Institute of Surgical Research at 1 site in United States.
Trial summary
The purpose of this study is to see if a drug called ondansetron (Zofran) controls itching from healing burn wounds as well or better than the usual drug used, diphenhydramine (Benadryl). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Itching
- What is being tested?
- Ondansetron (Zofran) and Diphenhydramine (Benadryl)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to May 2006
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females; 18 years or older.
- Seen in the United States Army Institute of Surgical Research (USAISR) Burn Clinic with healing burn wounds of any percent (%) of total body surface area (TBSA) causing pruritus
- Stable medical condition
- Negative pregnancy test and not nursing
- Able to indicate status of pruritus on a numeric scale
- Able to understand and read English
Who cannot join
- Unstable medical condition as determined by attending burn surgeon
- Prisoner
- History of allergic reaction to serotonin inhibitors or diphenhydramine
- Pregnant or lactating
- Unable to verbalize pruritus intensity scale
- Unable to understand or read English
Trial locations and contacts
1 site in 1 country.
United States1 site
US Army Institute of Surgical Research
Fort Sam Houston, Texas, 78234
About this study
Official title: A Pilot Study to Determine the Pruritic Benefits of Ondansetron Versus Diphenhydramine in Burn Patients Undergoing Wound Healing
The purpose of this study is to see if a drug called ondansetron (Zofran) controls itching from healing burn wounds as well or better than the usual drug used, diphenhydramine (Benadryl).
Read the detailed description
A clear mechanism or cause for pruritus in patients recovering from burn has not been delineated.
While the exact mechanisms/pathways for itching are currently unclear, histamine antagonism appears to be the most popular treatment. Whether histamine antagonism works predominantly via peripheral inhibition or central sedation is uncertain. By treating another intermediary in the pruritus cascade, it may be possible that an alternate treatment could be used while eliminating some of the unwanted side effects of antihistamine at the same time.
- Conditions
- Itching
- Being tested
- Ondansetron (Zofran), Diphenhydramine (Benadryl)
- Keywords
- pruritus, burn wound
- Medical subject headings
- Pruritus, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ondansetron (Zofran)Drug
Diphenhydramine (Benadryl)Drug
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | Not described Receives: Drug: Ondansetron (Zofran); Drug: Diphenhydramine (Benadryl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ondansetron will have a greater ability to control pruritus in burn patients who are undergoing wound healing when compared to the standard of care, diphenhydramine.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2005 (estimated)
- Study startJun 2005
- Primary completionMay 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ItchingStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Army Institute of Surgical Research
- Sponsor type
- US federal agency
- Investigators
- Stuart Gross, MD, Principal investigator, Wilford Hall Medical Center, Lackland AFB, San Antonio, TXSteven E Wolf, MD, Study director, US Army Institute of Surgical Research, Fort Sam Houston, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00137202
- Sponsor's protocol ID
- H-04-006
- Status last verified
- Jul 2008
- First submitted
- 25 Aug 2005
- Last updated
- 28 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Matheson JD, Clayton J, Muller MJ. The reduction of itch during burn wound healing. J Burn Care Rehabil. 2001 Jan-Feb;22(1):76-81; discussion 75. doi: 10.1097/00004630-200101000-00017.
PubMed 11227690
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Determine the Pruritic Benefits of Ondansetron Versus Diphenhydramine in Burn Patients Undergoing Wound Healing
- ClinicalTrials.gov ID
- NCT00137202
- Acronym / sponsor ID
- H-04-006
- Conditions
- Itching
- Keywords
- pruritus, burn wound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- United States Army Institute of Surgical ResearchUS federal agency
- Study start
- Jun 2005
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 29 Aug 2005 (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 see if a drug called ondansetron (Zofran) controls itching from healing burn wounds as well or better than the usual drug used, diphenhydramine (Benadryl).
Detailed description
A clear mechanism or cause for pruritus in patients recovering from burn has not been delineated.
While the exact mechanisms/pathways for itching are currently unclear, histamine antagonism appears to be the most popular treatment. Whether histamine antagonism works predominantly via peripheral inhibition or central sedation is uncertain. By treating another intermediary in the pruritus cascade, it may be possible that an alternate treatment could be used while eliminating some of the unwanted side effects of antihistamine at the same time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Drug: Ondansetron (Zofran), Drug: Diphenhydramine (Benadryl) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males or females; 18 years or older.
- Seen in the United States Army Institute of Surgical Research (USAISR) Burn Clinic with healing burn wounds of any percent (%) of total body surface area (TBSA) causing pruritus
- Stable medical condition
- Negative pregnancy test and not nursing
- Able to indicate status of pruritus on a numeric scale
Key exclusion criteria (6 listed)
- Unstable medical condition as determined by attending burn surgeon
- Prisoner
- History of allergic reaction to serotonin inhibitors or diphenhydramine
- Pregnant or lactating
- Unable to verbalize pruritus intensity scale
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 |
|---|---|---|
| Ondansetron (Zofran) | Drug | 2 |
| Diphenhydramine (Benadryl) | Drug | 2 |
Primary outcome
Ondansetron will have a greater ability to control pruritus in burn patients who are undergoing wound healing when compared to the standard of care, diphenhydramine.
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2008.
- Background: PubMed 11227690Matheson JD, Clayton J, Muller MJ. The reduction of itch during burn wound healing. J Burn Care Rehabil. 2001 Jan-Feb;22(1):76-81; discussion 75. doi: 10.1097/00004630-200101000-00017.
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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.
Stuart Gross, MD principal investigator
Wilford Hall Medical Center, Lackland AFB, San Antonio, TX
Steven E Wolf, MD study director
US Army Institute of Surgical Research, Fort Sam Houston, TX
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ondansetron (Zofran) and Diphenhydramine (Benadryl) in people with Itching, run by United States Army Institute of Surgical Research 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 28 Jul 2008. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ondansetron will have a greater ability to control pruritus in burn patients who are undergoing wound healing when compared to the standard of care, diphenhydramine. (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00137202, which also lists 1 linked publication.
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 28 Jul 2008.