Fracture Distal RadiusPhase 3NCT01017315
Efficacy of Baby Talcum in Prevention of Pruritus Assosiated With Cast
A Phase 3 study testing Baby talcum in people with Fracture Distal Radius, run by Prince of Songkla University at 1 site in Thailand.
Trial summary
This study aims to evaluate the efficacy of baby talcum in prevent pruritus after cast application in orthopaedic patients. The investigators will do a randomized controlled trial in patient with fracture distal end of radius treated conservatively. Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Fracture Distal Radius
- What is being tested?
- Baby talcum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteThailand
- Study dates
- Jul 2009to Oct 2012
- Phase
- Phase 3
- 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 15 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Fracture distal end radius treated conservatively
Who cannot join
- open fracture
- skin disease and wound under cast area
- Fracture distal end radius needed surgical management
- Allergy to baby talcum
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Prince of Songkla university
Hat Yai, Changwat Songkhla, 90110
About this study
Official title: Efficacy of Baby Talcum in Prevention of Pruritus Assosiated With Cast; a Randomized Controlled Trial
This study aims to evaluate the efficacy of baby talcum in prevent pruritus after cast application in orthopaedic patients.
The investigators will do a randomized controlled trial in patient with fracture distal end of radius treated conservatively.
Pruritus score and satisfaction will be monitor along the entire course of cast retention.
- Conditions
- Fracture Distal Radius
- Being tested
- Baby talcum
- Keywords
- baby talcum, pruritus, cast
- Medical subject headings
- Wrist Fractures, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baby talcumDrug
Also called "Care" brand of baby talcum
50 grams apply locally prior cast application
| Study group | Role | What they receive |
|---|---|---|
| No application of baby talcum | Experimental | control Receives: Drug: Baby talcum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pruritus score
Measured: 2 years
Secondary outcomes (3)
Satisfaction score
Measured: 2 years
Complication rate
Measured: 2 years
Number of antihistamine drugs used
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2009 (estimated)
- Study startJul 2009
- Primary completionJul 2012 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture Distal RadiusStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Boonsin Tangtrakulwanich, Prince of Songkla University
- Investigators
- Boonsin Tangtrakulwanich, MD.,Ph.D, Principal investigator, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01017315
- Sponsor's protocol ID
- 52-197-11-4-2
- Status last verified
- May 2012
- First submitted
- 17 Nov 2009
- Last updated
- 15 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Baby Talcum in Prevention of Pruritus Assosiated With Cast; a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01017315
- Acronym / sponsor ID
- 52-197-11-4-2
- Conditions
- Fracture Distal Radius
- Keywords
- baby talcum, pruritus, cast
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 20 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.
This study aims to evaluate the efficacy of baby talcum in prevent pruritus after cast application in orthopaedic patients.
The investigators will do a randomized controlled trial in patient with fracture distal end of radius treated conservatively.
Pruritus score and satisfaction will be monitor along the entire course of cast retention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No application of baby talcum | Experimental | Drug: Baby talcumcontrol |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Fracture distal end radius treated conservatively
Key exclusion criteria (4 listed)
- open fracture
- skin disease and wound under cast area
- Fracture distal end radius needed surgical management
- Allergy to baby talcum
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 |
|---|---|---|
| Baby talcumAlso: "Care" brand of baby talcum50 grams apply locally prior cast application | Drug | No application of baby talcum |
Primary outcome
Pruritus score
Time frame: 2 years
3 secondary outcomes
Satisfaction score
Time frame: 2 years
Complication rate
Time frame: 2 years
Number of antihistamine drugs used
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2012.
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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.
Boonsin Tangtrakulwanich, MD.,Ph.D principal investigator
Prince of Songkla University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Baby talcum in people with Fracture Distal Radius, run by Prince of Songkla University at 1 site in Thailand.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 15 May 2012. 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 Thailand. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Pruritus score (time frame: 2 years). 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 15 May 2012.