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Characterization of Pain Processing Mechanisms in Irritable Bowel Syndrome
NCT00108446 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG fentanyl
- DRUG dextromethorphan
- DRUG naloxone
- DRUG lidocaine
Study Locations (1)
Florida
- Malcom Randall VAMC — Gainesville
Trial Details
| Field | Value |
|---|---|
| Start Date | 2003-10 |
| Est. Completion | 2006-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00108446
The ClinicalTrials.gov registry entry for NCT00108446 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is US Department of Veterans Affairs, which has 158 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Irritable Bowel Syndrome appearing as the primary indexed condition, and to 4 interventions — of which fentanyl is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00108446 reports 1 study location spanning 1 distinct geographic area — top geographies include Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00108446 about?
NCT00108446 is a clinical study titled "Characterization of Pain Processing Mechanisms in Irritable Bowel Syndrome". 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, dextrom...
What is the current status of trial NCT00108446?
This trial is currently completed. It is a Phase 2 study. The study started on 2003-10. Estimated completion is 2006-03.
What conditions does trial NCT00108446 study?
This clinical trial studies the following conditions: Irritable Bowel Syndrome. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00108446?
The interventions under investigation include: fentanyl (DRUG), dextromethorphan (DRUG), naloxone (DRUG), lidocaine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00108446?
This trial is sponsored by US Department of Veterans Affairs, which has 158 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00108446 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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