Irritable Bowel SyndromeNCT00100425
Characterization of Pain Processing Mechanisms in Irritable Bowel Syndrome
A study testing Viceral Perception Testing in people with Irritable Bowel Syndrome, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The purpose of this study is to provide new information and to determine which kinds of brief, tolerable, experimental pain are affected by the drugs being studied in patients with irritable bowel syndrome, a disease that causes chronic abdominal pain. Read more about this study
- Who is it for?
- Ages 18 to 72 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Viceral Perception Testing
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Sep 2000to not given
- 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 72 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
- Patients with irritable bowel syndrome and healthy pain-free individuals (as controls) will be studied.
- No medical condition that would contraindicate use of dextromethorphan, fentanyl or naloxone.
Trial locations and contacts
1 site in 1 country.
United States1 site
Malcolm Randall VA Medical Center
Gainesville, Florida, 32608
About this study
Official title: Central Nervous System Modulation of Visceral Pain in Persian Gulf War Syndrome
The purpose of this study is to provide new information and to determine which kinds of brief, tolerable, experimental pain are affected by the drugs being studied in patients with irritable bowel syndrome, a disease that causes chronic abdominal pain. The effects of dextromethorphan, naloxone, and fentanyl on experimental pain stimuli will be tested in these studies to better understand what causes irritable bowel syndrome.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Viceral Perception Testing
- Keywords
- Irritable Bowel Syndrome, Visceral Hypersensitivity, Visceral Pain
- Medical subject headings
- Irritable Bowel Syndrome, Visceral Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viceral Perception TestingProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2004 (estimated)
- Study startSep 2000
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.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00100425
- Sponsor's protocol ID
- CADE-ARCD2
- Status last verified
- Dec 2004
- First submitted
- 30 Dec 2004
- Last updated
- 21 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Nervous System Modulation of Visceral Pain in Persian Gulf War Syndrome
- ClinicalTrials.gov ID
- NCT00100425
- Acronym / sponsor ID
- CADE-ARCD2
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable Bowel Syndrome, Visceral Hypersensitivity, Visceral Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Sep 2000
- First posted
- 31 Dec 2004 (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 provide new information and to determine which kinds of brief, tolerable, experimental pain are affected by the drugs being studied in patients with irritable bowel syndrome, a disease that causes chronic abdominal pain. The effects of dextromethorphan, naloxone, and fentanyl on experimental pain stimuli will be tested in these studies to better understand what causes irritable bowel syndrome.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Viceral Perception Testing | Procedure or surgery | – |
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 21 Jan 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Viceral Perception Testing in people with Irritable Bowel Syndrome, run by US Department of Veterans Affairs 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?
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 21 Jan 2009. 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 21 Jan 2009.