Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Department of Veterans Affairs |
---|---|
Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00108446 |
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.
Condition | Intervention | Phase |
---|---|---|
Irritable Bowel Syndrome |
Drug: dextromethorphan Drug: naloxone Drug: fentanyl Drug: lidocaine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | Characterization of Pain Processing Mechanisms in Irritable Bowel Syndrome |
Study Start Date: | October 2003 |
Estimated Study Completion Date: | March 2006 |
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 #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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | CLIN-008-02F |
Study First Received: | April 15, 2005 |
Last Updated: | May 15, 2007 |
ClinicalTrials.gov Identifier: | NCT00108446 |
Health Authority: | United States: Federal Government |
Irritable Bowel Syndrome visceral hypersensitivity cutaneous hypersensitivity lidocaine |
Excitatory Amino Acids Fentanyl Gastrointestinal Diseases Colonic Diseases Lidocaine Pain Intestinal Diseases Naloxone Naphazoline |
Oxymetazoline Hypersensitivity Digestive System Diseases Guaifenesin Phenylephrine Irritable Bowel Syndrome Dextromethorphan Phenylpropanolamine Colonic Diseases, Functional |
Respiratory System Agents Neurotransmitter Agents Disease Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Central Nervous System Depressants Anesthetics Excitatory Amino Acid Agents Cardiovascular Agents Anesthetics, Local |
Pharmacologic Actions Pathologic Processes Sensory System Agents Syndrome Therapeutic Uses Anti-Arrhythmia Agents Peripheral Nervous System Agents Antitussive Agents Central Nervous System Agents Excitatory Amino Acid Antagonists |