Irritable Bowel SyndromeNCT00065754
Brain Imaging and Pain in Irritable Bowel Syndrome
A study of Irritable Bowel Syndrome, run by University of Florida at 1 site in United States.
Trial summary
This study examines the mechanisms, including brain imaging of placebo analgesia Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Irritable Bowel Syndrome
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Dec 2007
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Irritable Bowel Syndrome
- English speaking
Who cannot join
- Chronic pain condition other than Irritable Bowel Syndrome
- Medical condition that would contraindicate use of lidocaine
- Clinical criteria for fibromyalgia
- Presence of systemic disease such as diabetes, thyroid, gastrointestinal or liver disease, collagen vascular disease, malignancy, focal or neurological
- Seropositive HIV
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brain Imaging and Pain: Analysis of Placebo Analgesia
This study examines the mechanisms, including brain imaging of placebo analgesia
- Conditions
- Irritable Bowel Syndrome
- Being tested
- placebo
- Keywords
- Placebo, Analgesia, Pain, Brain mechanism, Expectation
- Medical subject headings
- Irritable Bowel Syndrome, Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2003 (estimated)
- Study startSep 2003
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor
- Investigators
- Michael E Robinson, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00065754
- Sponsor's protocol ID
- R01AT001424-01
- Other IDs
- R01AT001424-01
- Status last verified
- Aug 2011
- First submitted
- 31 Jul 2003
- Last updated
- 20 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Imaging and Pain: Analysis of Placebo Analgesia
- ClinicalTrials.gov ID
- NCT00065754
- Acronym / sponsor ID
- R01AT001424-01
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Placebo, Analgesia, Pain, Brain mechanism, Expectation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Sep 2003
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 1 Aug 2003 (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 examines the mechanisms, including brain imaging of placebo analgesia
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Irritable Bowel Syndrome
- English speaking
Key exclusion criteria (6 listed)
- Chronic pain condition other than Irritable Bowel Syndrome
- Medical condition that would contraindicate use of lidocaine
- Clinical criteria for fibromyalgia
- Presence of systemic disease such as diabetes, thyroid, gastrointestinal or liver disease, collagen vascular disease, malignancy, focal or neurological
- Seropositive HIV
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 |
|---|---|---|
| placebo | Drug | – |
Primary outcome
Not reported in the source record.
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 20 Sep 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.
Michael E Robinson, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Irritable Bowel Syndrome, run by University of Florida 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 2 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 20 Sep 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. 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.
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 20 Sep 2011; AzTrials last refreshed its copy on 6 Nov 2026.