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Intrathecal Ziconotide Effectiveness and Safety Trial in Patients with Chronic Severe Pain Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Intrathecal Ziconotide Effectiveness and Safety Trial in Patients with Chronic Severe Pain conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Intrathecal Ziconotide Effectiveness and Safety Trial in Patients with Chronic Severe Pain Clinical research trials and Intrathecal Ziconotide Effectiveness and Safety Trial in Patients with Chronic Severe Pain health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Intrathecal Ziconotide Effectiveness and Safety Trial in Patients with Chronic Severe Pain. Intrathecal Ziconotide Effectiveness and Safety Trial in Patients with Chronic Severe Pain Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Intrathecal Ziconotide Effectiveness and Safety Trial in Patients with Chronic Severe Pain clinical trial. Human subjects often get the best healthcare possible for their Intrathecal Ziconotide Effectiveness and Safety Trial in Patients with Chronic Severe Pain condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "I" Clinical Trials Conditions > Intrathecal Ziconotide Effectiveness and Safety Trial in Patients with Chronic Severe Pain  Intrathecal Ziconotide Effectiveness and Safety Trial in Patients with Chronic Severe Pain
Intrathecal Ziconotide Effectiveness and Safety Trial in Patients with Chronic Severe Pain
For Condition: Pain
Status: Recruiting
Sponsor(s): Elan Pharmaceuticals ,
Synopsis: An open-label study desinged to give chronic severe pain patients with existing intrathecal pump systems access to ziconotide.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Expanded Access Assignment, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Each patient must have chronic severe pain of malignant or nonmalignant etiology with inadequate pain relief from or intolerance to conventional therapy. - Each patient must have a predicted life expectancy of greater than or equal to 6 weeks relative to baseline. - Each patient must be able to respond to the Visual Analog Scale of Pain Intensity (VASPI). - Each patient must have an implanted programmable SynchroMed infusion device or a CADD-Micro external programmable infusion device and spinal catheter (hereafter "IT pump and spinal catheter") prior to enrollment into this trial. (If a patient has an external pump, the Investigator must ensure that the patient is at a low risk for infection and that the patient is capable of maintaining good personal hygiene. The Investigator must have demonstrated the ability to successfully manage patients with external pumps prior to enrolling a patient in this trial.) - Each patient must be at least 18 years of age. - Each patient must be competent to give written informed consent and has given written informed consent prior to performance of any study-related procedures. Reasonable accomodation of visually impaired patients will be allowed. - Each patient is willing and able to comply with the protocol requirements. - Each female patient of childbearing potential must agree to use adequate contraceptive methods while on PRIALT as determine by the Investigator. Exclusion Criteria: - Presence of pregnancy or lactation. - Participation in another investigational drug or device trial within the preceding 30 days. - Presence of known hypersensitivity to PRIALT or any of its components. - Presence of any contraindication to continued IT therapy (for example, infection at the pump or catheter externalization site, uncontrolled bleeding diathesis, spinal canal obstruction that impairs cerebrospinal fluid (CSF) circulation, or patient and caregiver inability to manage and protect the IT pump and spinal catheter system and return for clinic follow up visits). - Presence of any condition (for example, psychosis, severe depression or suicidal ideation, homicidality, somatization disorder, active substance abuse, cognitive deficits, dementia or other serious medical or psychiatric condition) that in the Investigator's opinion precludes the patient's ability to participate in this study.
Total Enrollment: 300
Location and Contact Information:
Dr. O'Connell's Pain Care Centers, Inc. *Recruiting*
Somersworth, New Hampshire, 03878
United States
Recruiting Leah Bagley 603-692-3166
Lifetree Clinical Research *Recruiting*
Salt Lake City, Utah, 84106
United States
Recruiting Sarah Jones 801-269-9415
Outcomes Research International *Recruiting*
Tucson, Arizona, 85712
United States
Recruiting Chris Arslanian 520-514-7600
Galileo Surgery Center *Recruiting*
San Luis Obispo, California, 93405
United States
Recruiting Edward Bowie 805-782-8222
Comprehensive Pain and Headache Treatment Centers, LLC *Recruiting*
Derby, Connecticut, 06418
United States
Recruiting Kathy Carboni 203-732-1584
All Island Pain Consultants *Recruiting*
Bay Shore, New York, 11706
United States
Recruiting Christine Wallace 631-661-6001
Bay Area Pain Center *Recruiting*
Los Gatos, California, 95032
United States
Recruiting Amy Ouimette 408-364-6799
Pacific Pain Treatment Centers *Recruiting*
San Francisco, California, 94109
United States
Recruiting Valentina Apostol 415-567-1219
Clinical Pharmacology Services *Recruiting*
Tampa, Florida, 33617
United States
Recruiting Dawn Welchans 813-983-1500
Rocky Mountain Clinical Research *Recruiting*
Golden, Colorado, 80401
United States
Recruiting Gail Danhour 303-279-1550
Shreenath Clinical Services *Recruiting*
Beverly Hills, California, 90211
United States
Recruiting Hemangini Patel 714-964-7852
Lehigh Valley Hospital *Recruiting*
Allentown, Pennsylvania, 18103
United States
Recruiting Mary Cerrone 610-402-9003
Shreenath Clinical Services *Recruiting*
Long Beach, California, 90807
United States
Recruiting Lubna Ajmal 714-964-7852
The University of Chicago, Dept. of Surgery, Section of Neurosurgery *Recruiting*
Chicago, Illinois, 60637
United States
Recruiting Lori Loftis 773-702-4632
Shreenath Clinical Services *Recruiting*
Lake Forest, California, 92630
United States
Recruiting Ben Yelles 714-964-7852
Pain Relief Center of Colorado *Recruiting*
Arvada, Colorado, 80002
United States
Recruiting Jim Villhauer 303-431-5060
Pain Control Network, PSC/PCN Surgical Suites, LLC *Recruiting*
Louisville, Kentucky, 40205
United States
Recruiting Eva Gaines 502-897-3500
Additional Information:
Study ID Numbers: ELN92045-501;
Study Start Date: February 2004
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00076544
Other Pain Studies:
1. Massage for the Treatment of Cancer-Related Pain
2. Tolerability of Three Local Anesthetic Formulations in Conjunction with NGX-4010 for the Treatment of Neuropathic Pain
3. Combination Chemotherapy in Treating Pain in Patients With Hormone Refractory Metastatic Prostate Cancer
4. Lidocaine Patch in Treating Cancer Patients with Neuropathic Pain After Surgery
5. Treatment of Chronic Pain after Spinal Cord Injury (SCI) or Amputation
Related Studies:
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Intrathecal Ziconotide Effectiveness and Safety Trial in Patients with Chronic Severe Pain
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