Healthy AdultsNCT02290665
Localized Therapeutics for the Treatment of Gastrointestinal Disorders
A study testing Thermosensitive gel rectal formulation and Saline enema in people with Healthy Adults, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to determine the patient preference for a biocompatible thermosensitive solution-gel versus water or saline (liquid) enema. The thermosensitive solution-gel is comprised of poloxamer, an inactive compound that is designated as GRAS (generally recognized as safe) by FDA. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- Thermosensitive gel rectal formulation and Saline enema
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2015to 28 Sep 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Generally healthy
- Age 18 to 70 years old
- Non-pregnant
Who cannot join
- GI complaints
- Pregnancy
- Patients with previous colonic surgery or current bowel injury or obstruction
- Allergies to contrast
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the patient preference for a biocompatible thermosensitive solution-gel versus water or saline (liquid) enema. The thermosensitive solution-gel is comprised of poloxamer, an inactive compound that is designated as GRAS (generally recognized as safe) by FDA. It could subsequently be used as a medium for drug delivery. The poloxamer (gel) is administered to study participants in order to assess preference and proximal distribution.
- Conditions
- Healthy Adults
- Being tested
- Thermosensitive gel rectal formulation, Saline enema
- Keywords
- enema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermosensitive gel rectal formulationOther
Saline enemaOther
| Study group | Role | What they receive |
|---|---|---|
| Thermosensitive gel formulation | Experimental | Thermosensitive gel rectal formulation or saline (control) enema with crossover to the other. Receives: Other: Thermosensitive gel rectal formulation; Other: Saline enema |
| Saline enema | Experimental | Thermosensitive gel rectal formulation or saline (control) enema with crossover to the other. Receives: Other: Thermosensitive gel rectal formulation; Other: Saline enema |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient preference, as assessed by questionnaire
Measured: Up to 3 hours post-administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2014 (estimated)
- Study start30 Jan 2015
- Primary completion28 Sep 2015
- Study completion28 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultsStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sidhartha R Sinha, Stanford University
- Investigators
- Sidhartha Sinha, MD, Principal investigator, Stanford UniversityAida Habtezion, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02290665
- Sponsor's protocol ID
- IRB-29620
- Status last verified
- Aug 2018
- First submitted
- 6 Nov 2014
- Last updated
- 16 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Localized Therapeutics for the Treatment of Gastrointestinal Disorders
- ClinicalTrials.gov ID
- NCT02290665
- Acronym / sponsor ID
- IRB-29620
- Conditions
- Healthy Adults
- Keywords
- enema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 30 Jan 2015 (actual)
- Primary completion
- 28 Sep 2015 (actual)
- Study completion
- 28 Sep 2015 (actual)
- First posted
- 14 Nov 2014 (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 the patient preference for a biocompatible thermosensitive solution-gel versus water or saline (liquid) enema. The thermosensitive solution-gel is comprised of poloxamer, an inactive compound that is designated as GRAS (generally recognized as safe) by FDA. It could subsequently be used as a medium for drug delivery. The poloxamer (gel) is administered to study participants in order to assess preference and proximal distribution.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thermosensitive gel formulation | Experimental | Other: Thermosensitive gel rectal formulation, Other: Saline enemaThermosensitive gel rectal formulation or saline (control) enema with crossover to the other. |
| Saline enema | Experimental | Other: Thermosensitive gel rectal formulation, Other: Saline enemaThermosensitive gel rectal formulation or saline (control) enema with crossover to the other. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Generally healthy
- Age 18 to 70 years old
- Non-pregnant
Key exclusion criteria (4 listed)
- GI complaints
- Pregnancy
- Patients with previous colonic surgery or current bowel injury or obstruction
- Allergies to contrast
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 |
|---|---|---|
| Thermosensitive gel rectal formulation | Other | Saline enema, Thermosensitive gel formulation |
| Saline enema | Other | Saline enema, Thermosensitive gel formulation |
Primary outcome
Patient preference, as assessed by questionnaire
Time frame: Up to 3 hours post-administration
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 16 Aug 2018.
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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.
Sidhartha Sinha, MD principal investigator
Stanford University
Aida Habtezion, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermosensitive gel rectal formulation and Saline enema in people with Healthy Adults, run by Stanford University 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 3 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: finished, as of the sponsor's last update on 16 Aug 2018. 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?
Patient preference, as assessed by questionnaire (time frame: Up to 3 hours post-administration). 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 16 Aug 2018.