Spots Global Cancer Trial Database for Long-Term Safety and Tolerability Study of NKTR-181 in Subjects With Chronic Low Back Pain or Chronic Non-Cancer Pain
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Trial Identification
Brief Title: Long-Term Safety and Tolerability Study of NKTR-181 in Subjects With Chronic Low Back Pain or Chronic Non-Cancer Pain
Official Title: A Phase 3 Multicenter, Open-Label, 52-Week Study To Evaluate the Long-Term Safety and Tolerability of NKTR-181 in Subjects With Moderate to Severe Chronic Low Back Pain or Chronic Non-Cancer Pain
Study ID: NCT02367820
Interventions
Study Description
Brief Summary: The purpose of this 52-week open label study is to determine the long-term safety of a new opioid molecule, NKTR-181, in patients with moderate to severe chronic low back pain or chronic non-cancer pain.
Detailed Description: This is an open-label safety and tolerability study in which approximately 600 subjects will receive NKTR-181 for up to 52 weeks. Subjects may include newly enrolled subjects and subjects who have recently completed SUMMIT-07 study. This study will also investigate the pharmacokinetics of NKTR-181 in patients with chronic low back pain or chronic non-cancer pain.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Investigator Site - Saraland, Saraland, Alabama, United States
Investigator Site - Phoenix, Phoenix, Arizona, United States
Investigator Site - Tempe, Tempe, Arizona, United States
Investigator Site - Little Rock, Little Rock, Arkansas, United States
Investigator Site - Stamford, Stamford, Connecticut, United States
Investigator Site - Clearwater, Clearwater, Florida, United States
Investigator Site - Fort Lauderdale, Fort Lauderdale, Florida, United States
Investigator Site - Fort Myers, Fort Myers, Florida, United States
Investigator Site - Jacksonville, Jacksonville, Florida, United States
Investigator Site - Orlando, Orlando, Florida, United States
Investigator Site - Ormond Beach, Ormond Beach, Florida, United States
Investigator Site - Plantation, Plantation, Florida, United States
Investigator Site - Tampa, Tampa, Florida, United States
Investigator Site - West Palm Beach, West Palm Beach, Florida, United States
Investigator Site - Atlanta, Atlanta, Georgia, United States
Investigator Site - Blue Ridge, Blue Ridge, Georgia, United States
Investigator Site - Marietta, Marietta, Georgia, United States
Investigator Site - Norcross, Norcross, Georgia, United States
Investigator Site - Gurnee, Gurnee, Illinois, United States
Investigator Site - West Des Moines, West Des Moines, Iowa, United States
Investigator Site - Wichita, Wichita, Kansas, United States
Investigator Site - Louisville, Louisville, Kentucky, United States
Investigator Site - Bossier, Bossier City, Louisiana, United States
Investigator Site - New Orleans, New Orleans, Louisiana, United States
Investigator Site - Shreveport, Shreveport, Louisiana, United States
Investigator Site - Bay City, Bay City, Michigan, United States
Investigator Site - Pinconning, Pinconning, Michigan, United States
Investigator Site - Biloxi, Biloxi, Mississippi, United States
Investigator Site - Saint Louis 1, Saint Louis, Missouri, United States
Investigator Site - Saint Louis 2, Saint Louis, Missouri, United States
Investigator Site - Omaha, Omaha, Nebraska, United States
Investigator Site - Las Vegas 2, Las Vegas, Nevada, United States
Investigator Site - Las Vegas 1, Las Vegas, Nevada, United States
Investigator Site - Rochester, Rochester, New York, United States
Investigator Site - Williamsville, Williamsville, New York, United States
Investigator Site - Greensboro, Greensboro, North Carolina, United States
Investigator Site - Winston Salem, Winston-Salem, North Carolina, United States
Investigator Site - Fargo, Fargo, North Dakota, United States
Investigator Site - Beavercreek, Beavercreek, Ohio, United States
Investigator Site - Cincinnati 1, Cincinnati, Ohio, United States
Investigator Site - Cincinnati 2, Cincinnati, Ohio, United States
Investigator Site - Columbus, Columbus, Ohio, United States
Investigator Site - Duncansville, Duncansville, Pennsylvania, United States
Investigator Site - Jenkintown, Jenkintown, Pennsylvania, United States
Investigator Site - Dakota Dunes, Dakota Dunes, South Dakota, United States
Investigator Site - Rapid City, Rapid City, South Dakota, United States
Investigator Site - Memphis, Memphis, Tennessee, United States
Investigator Site - Arlington, Arlington, Texas, United States
Investigator Site - Austin, Austin, Texas, United States
Investigator Site - Killeen, Killeen, Texas, United States
Investigator Site - San Antonio, San Antonio, Texas, United States
Investigator Site - Salt Lake City, Salt Lake City, Utah, United States
Investigator Site - West Jordan, West Jordan, Utah, United States
Investigator Site - Midlothian, Midlothian, Virginia, United States
Investigator Site - Norfolk, Norfolk, Virginia, United States
Investigator Site - Kenosha, Kenosha, Wisconsin, United States
Contact Details
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