Irritable Bowel SyndromePhase 2NCT00108446
Characterization of Pain Processing Mechanisms in Irritable Bowel Syndrome
A Phase 2 study testing dextromethorphan, naloxone and fentanyl in people with Irritable Bowel Syndrome, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
This study is being done to collect new information on irritable bowel syndrome, a disease that causes abdominal pain that does get better with treatment or keeps coming back ("chronic"). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- dextromethorphan, naloxone and fentanyl
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Mar 2006
- Phase
- Phase 2
- 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
- Premenopausal women age 18 years or older OR healthy controls
- Patients with diarrhea predominant IBS that meet the *Rome II criteria
- The subject must speak English and be able to give informed consent
- All subjects will be tested in the follicular stage of the menstrual cycle as determined by menstrual history and urine testing
- Functional Bowel Disorder Severity Index score of none (0 points) for controls and moderate (37-110 points) for IBS patients
- Normal baseline EKG
Who cannot join
- Subject is currently participating in another research protocol that could interfere or influence the outcome measures of the present study
- Subject is unable to give informed consent
- A medical condition that would contraindicate the use of lidocaine (i.e., amide allergy) or a previous history of an abnormal EKG
- Subjects with a positive pregnancy test will be excluded because the use of lidocaine is contraindicated in pregnant women
- Subject is currently taking pain medications, NSAIDs, antihistaminics, antidepressants (tricyclic antidepressants [TCA]/selective serotonin reuptake inhibitors [SSRI]), anti-convulsants, migraine medications, and cough suppressants
- Presence of systemic disease: diabetes, thyroid disease, gastrointestinal/liver disease (other than IBS), collagen vascular disease, focal or systemic neurological disease, malignancy, seropositive for HIV, or documented psychiatric disorders
Show all 10Show fewer
- Presence of any chronic pain condition including fibromyalgia
- Subject drinks > 2 oz. alcohol/day on a regular basis
- Presence of large, palpable hemorrhoids on digital rectal exam that may alter rectal lidocaine adherence to rectal wall
- Abnormal baseline EKG
Trial locations and contacts
1 site in 1 country.
About this study
This study is being done to collect new information on irritable bowel syndrome, a disease that causes abdominal pain that does get better with treatment or keeps coming back ("chronic"). To better understand what causes the irritable bowel syndrome, we are studying drugs used to treat pain, dextromethorphan, naloxone, fentanyl, and lidocaine. We will study the effects these drugs have on experimental pain.
Dextromethorphan is used in non-prescription cough syrups. Naloxone is used for reversing the effects of narcotic pain relievers. Fentanyl is a narcotic used to treat pain and to make a person relaxed (sedated) before anesthesia. The purpose of this study is to see what kinds of pain are affected by these drugs in persons who have irritable bowel syndrome and persons who do not have this problem.
Read the detailed description
Irritable Bowel Syndrome (IBS) is a common gastrointestinal disorder characterized by chronic abdominal pain and altered bowel function (diarrhea and/or constipation) that effects up to 20% of the United States population. Although the pathophysiology of IBS is unknown, visceral hypersensitivity (i.e., decreased pain thresholds in response to gut distension) is a biological marker of the disorder. The mechanisms that lead to visceral hypersensitivity, however, are currently unknown. As a consequence of our current VA-supported studies, our laboratory has acquired evidence that patients with IBS and visceral hypersensitivity also have cutaneous hypersensitivity in response to experimental thermal pain stimuli. These new findings differ from previous investigations that indicated IBS-associated hypersensitivity is limited to the gut. Rather, our data suggest that patients with IBS have alterations in central pain processing mechanisms that may represent the underlying pathophysiological basis for visceral and cutaneous hypersensitivity. Based on our preliminary data, we propose that alterations in spinal processing mechanisms are similar in patients with IBS to those that have been described for patients with other chronic pain disorders. Cutaneous hypersensitivity is also seen in other chronic pain conditions such as fibromyalgia where altered central pain processing mechanisms have been shown to be responsible for maintaining hypersensitivity. In our current proposal, we hypothesize that IBS patients have increased peripheral and central afferent processing of nociceptive cutaneous and visceral stimuli.
Our objectives are as follows:
- Specific Objective #1. To determine if lidocaine applied to the rectum decreases visceral hyperalgesia, as tested by nociceptive rectal distension.
- Specific Objective #2. To determine if lidocaine applied to the rectum decreases cutaneous heat hyperalgesia to test for the presence or absence of central hyperalgesia in IBS patients.
- Specific Objective #3. To determine the relationships between doses of IV lidocaine, serum levels of IV lidocaine, and their anti-hyperalgesic effects, as tested by rectal distension and cutaneous heat stimulation.
Specific Objective #4. To determine the effect of rectal lidocaine on clinical pain and clinical symptoms of IBS.
The proposed studies will test the central hypothesis using well-controlled sensory stimuli designed to separately evaluate central and peripheral mechanisms. The objectives will be accomplished by systematically applying and comparing pharmacological and psychophysical studies to IBS patients and controls. This application is an extension of the principal investigator's current VA Advanced Career Development Award that examines the neurobiology of visceral hypersensitivity in Persian Gulf veterans who returned home with chronic abdominal pain. The proposed Clinical Research Program will study afferent mechanisms of visceral and cutaneous hypersensitivity in veterans with IBS. Our laboratory is uniquely positioned to use our expertise in psychophysical and pharmacologic evaluation of patients with fibromyalgia to study patients with IBS. The results of this current proposal will lead to larger clinical trials with sodium-channel blockers (i.e., lidocaine, mexiletine) as potential therapeutic agents for veterans with IBS.
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable Bowel Syndrome, visceral hypersensitivity, cutaneous hypersensitivity, lidocaine
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2005 (estimated)
- Study startOct 2003
- Study completionMar 2006
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- NCT00108446
- Sponsor's protocol ID
- CLIN-008-02F
- Status last verified
- May 2007
- First submitted
- 15 Apr 2005
- 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
- Characterization of Pain Processing Mechanisms in Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT00108446
- Acronym / sponsor ID
- CLIN-008-02F
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable Bowel Syndrome, visceral hypersensitivity, cutaneous hypersensitivity, lidocaine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Oct 2003
- Study completion
- Mar 2006
- First posted
- 18 Apr 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.
This study is being done to collect new information on irritable bowel syndrome, a disease that causes abdominal pain that does get better with treatment or keeps coming back ("chronic"). To better understand what causes the irritable bowel syndrome, we are studying drugs used to treat pain, dextromethorphan, naloxone, fentanyl, and lidocaine. We will study the effects these drugs have on experimental pain.
Dextromethorphan is used in non-prescription cough syrups. Naloxone is used for reversing the effects of narcotic pain relievers. Fentanyl is a narcotic used to treat pain and to make a person relaxed (sedated) before anesthesia. The purpose of this study is to see what kinds of pain are affected by these drugs in persons who have irritable bowel syndrome and persons who do not have this problem.
Detailed description
Irritable Bowel Syndrome (IBS) is a common gastrointestinal disorder characterized by chronic abdominal pain and altered bowel function (diarrhea and/or constipation) that effects up to 20% of the United States population. Although the pathophysiology of IBS is unknown, visceral hypersensitivity (i.e., decreased pain thresholds in response to gut distension) is a biological marker of the disorder. The mechanisms that lead to visceral hypersensitivity, however, are currently unknown. As a consequence of our current VA-supported studies, our laboratory has acquired evidence that patients with IBS and visceral hypersensitivity also have cutaneous hypersensitivity in response to experimental thermal pain stimuli. These new findings differ from previous investigations that indicated IBS-associated hypersensitivity is limited to the gut. Rather, our data suggest that patients with IBS have alterations in central pain processing mechanisms that may represent the underlying pathophysiological basis for visceral and cutaneous hypersensitivity. Based on our preliminary data, we propose that alterations in spinal processing mechanisms are similar in patients with IBS to those that have been described for patients with other chronic pain disorders. Cutaneous hypersensitivity is also seen in other chronic pain conditions such as fibromyalgia where altered central pain processing mechanisms have been shown to be responsible for maintaining hypersensitivity. In our current proposal, we hypothesize that IBS patients have increased peripheral and central afferent processing of nociceptive cutaneous and visceral stimuli.
Our objectives are as follows:
- Specific Objective #1. To determine if lidocaine applied to the rectum decreases visceral hyperalgesia, as tested by nociceptive rectal distension.
- Specific Objective #2. To determine if lidocaine applied to the rectum decreases cutaneous heat hyperalgesia to test for the presence or absence of central hyperalgesia in IBS patients.
- Specific Objective #3. To determine the relationships between doses of IV lidocaine, serum levels of IV lidocaine, and their anti-hyperalgesic effects, as tested by rectal distension and cutaneous heat stimulation.
Specific Objective #4. To determine the effect of rectal lidocaine on clinical pain and clinical symptoms of IBS.
The proposed studies will test the central hypothesis using well-controlled sensory stimuli designed to separately evaluate central and peripheral mechanisms. The objectives will be accomplished by systematically applying and comparing pharmacological and psychophysical studies to IBS patients and controls. This application is an extension of the principal investigator's current VA Advanced Career Development Award that examines the neurobiology of visceral hypersensitivity in Persian Gulf veterans who returned home with chronic abdominal pain. The proposed Clinical Research Program will study afferent mechanisms of visceral and cutaneous hypersensitivity in veterans with IBS. Our laboratory is uniquely positioned to use our expertise in psychophysical and pharmacologic evaluation of patients with fibromyalgia to study patients with IBS. The results of this current proposal will lead to larger clinical trials with sodium-channel blockers (i.e., lidocaine, mexiletine) as potential therapeutic agents for veterans with IBS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Premenopausal women age 18 years or older OR healthy controls
- Patients with diarrhea predominant IBS that meet the *Rome II criteria
- The subject must speak English and be able to give informed consent
- All subjects will be tested in the follicular stage of the menstrual cycle as determined by menstrual history and urine testing
- Functional Bowel Disorder Severity Index score of none (0 points) for controls and moderate (37-110 points) for IBS patients
Key exclusion criteria (10 listed)
- Subject is currently participating in another research protocol that could interfere or influence the outcome measures of the present study
- Subject is unable to give informed consent
- A medical condition that would contraindicate the use of lidocaine (i.e., amide allergy) or a previous history of an abnormal EKG
- Subjects with a positive pregnancy test will be excluded because the use of lidocaine is contraindicated in pregnant women
- Subject is currently taking pain medications, NSAIDs, antihistaminics, antidepressants (tricyclic antidepressants [TCA]/selective serotonin reuptake inhibitors [SSRI]), anti-convulsants, migraine medications, and cough suppressants
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 |
|---|---|---|
| dextromethorphan | Drug | – |
| naloxone | Drug | – |
| fentanyl | Drug | – |
| lidocaine | 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 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 Phase 2 study testing dextromethorphan, naloxone and fentanyl 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?
The sponsor lists 6 inclusion and 10 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 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.