Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00108446
Status:
COMPLETED
Last Update Posted:
2009-01-21
First Post:
2005-04-15
Brief Title:
Characterization of Pain Processing Mechanisms in Irritable Bowel Syndrome
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Characterization of Pain Processing Mechanisms in Irritable Bowel Syndrome
Status:
COMPLETED
Status Verified Date:
2007-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 andor constipation that effects up to 20 of the United States population Although the pathophysiology of IBS is unknown visceral hypersensitivity ie 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 investigators 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 ie lidocaine mexiletine as potential therapeutic agents for veterans with IBS
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 investigators 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 ie lidocaine mexiletine as potential therapeutic agents for veterans with IBS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None