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NCT00804154 · ClinicalTrials.gov registry record · Phase 1
Resiniferatoxin to Treat Severe Pain Associated With Advanced Cancer
A Phase 1 study of Palliative Care and Intractable Pain, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
- 1
- Study location
NCT00804154 is a Phase 1 study of Palliative Care and Intractable Pain that is actively recruiting participants, run by National Institute of Dental and Craniofacial Research (NIDCR). The registered enrollment target is 45 participants, below the 1,414-participant average among 18 other Palliative Care trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00804154, a Phase 1 study of Palliative Care and Intractable Pain, is actively recruiting participants, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will examine the safety of giving the experimental drug, resiniferatoxin (RTX), to treat severe pain in patients with advanced cancer. RTX is a chemical extracted from a cactus-like plant. It is similar to capsaicin, the active ingredient in hot pepper. RTX has relieved pain and reduced the need for pain medication in several animal experiments. It works by destroying nerves that transmit pain information. People at least 18 years of age with severe pain from advanced cancer at or below the level of the chest that cannot be controlled with standard treatments may be eligible for this study. Participants undergo the following procedures: Pretreatment Visit Before beginning treatment with RTX, patients give a medical history and undergo a physical examination that includes: * Electrocardiogram (EKG) * Blood draw * Urinalysis * Neurological examinations * Peak expiratory flow rate (PEFR) * Eye examination * MRI * Urology assessment * Pregnancy test, when appropriate * Questionnaires to collect information on health, personality, mood, pain levels and symptoms. 2-Day Hospitalization Patients are hospitalized for 2 days for RTX injection and monitoring, as follows: * RTX injection: RTX is injected in the operating room under general anesthesia. It is given through a catheter placed in the patient s spine. The catheter is also used to obtain samples of cerebrospinal fluid (CSF) the clear fluid that bathes the spinal cord. The fluid is examined to assess drug effects and side effects, chemical changes in the content of the CSF associated with RTX, and how RTX is handled by the body. * Post-injection monitoring, including: * Surveys about symptoms such as pain or weakness * Neurological examinations * Blood and CSF sampling * EKG * AEs Outpatient followup * Vitals * Blood draw, Urinalysis, neurological and sensory testing, EKG on days 7, 14 and 30 after the injection * MRI scans of the head and back, Urology assessment and PEFR on day 15 after the inje
Conditions Studied
Interventions
- DRUG Intrathecal Resiniferatoxin
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2009-08-14 |
| Est. Completion | 2027-02-07 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00804154
The ClinicalTrials.gov registry entry for NCT00804154 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,414-participant average among 18 other Palliative Care trials with a reported enrollment target (97% lower). The listed sponsor is National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Palliative Care appearing as the primary indexed condition, and to 1 intervention - of which Intrathecal Resiniferatoxin is the first listed.
NCT00804154 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00804154 about?
NCT00804154 is a clinical study titled "Resiniferatoxin to Treat Severe Pain Associated With Advanced Cancer". This study will examine the safety of giving the experimental drug, resiniferatoxin (RTX), to treat severe pain in patients with advanced cancer. RTX is a chemical extracted from a cactus-like plant. It is similar to capsaicin, the active ingredient in hot pepper. RTX has relieved pain and reduced t...
What is the current status of trial NCT00804154?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2009-08-14. Estimated completion is 2027-02-07.
What conditions does trial NCT00804154 study?
This clinical trial studies the following conditions: Palliative Care, Intractable Pain.
What interventions are being tested in trial NCT00804154?
The interventions under investigation include: Intrathecal Resiniferatoxin (DRUG).
Who is sponsoring clinical trial NCT00804154?
This trial is sponsored by National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00804154 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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