Clinical trial NCT02367820: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Low Back Pain
Chronic Pain
Lead sponsor: Nektar Therapeutics
Sponsor class: INDUSTRY
First posted: 2015-02-20
Enrollment: 638
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Male or non-pregnant, non-nursing female aged 18 to 75 years old
* Clinical diagnosis of moderate to severe, chronic low back or non-cancer pain for at least three months
* Not experiencing adequate pain relief or have failed previous treatment with non-opioid analgesics
* Opioid analgesia is necessary
* Currently taking no less than 10 mg but no more than 60 mg of morphine sulfate equivalents (MSE) per day of opioid analgesics for at least 7 days prior to entry
* Females of child bearing potential must be using a highly effective form of birth control. All subjects must agree to use double-barrier contraception during participation in this study and for at least 2 months after the last dose of the study drug.
* Willing and able to provide informed consent

Exclusion Criteria:

* History of hypersensitivity, intolerance, or allergy to opioids
* Surgical procedures in the last 4 weeks or plans to undergo surgical procedures during the study period
* Untreated moderate to severe sleep apnea
* Chronic migraines as the primary pain condition
* Cancer related pain

Primary outcomes:
measure: Number of Participants Reporting Adverse Events
timeFrame: Screening baseline through end of study, an average of 57 weeks
Secondary outcomes:
measure: Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52
timeFrame: Baseline, monthly change from baseline till the end of study
measure: Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52
timeFrame: Baseline, monthly change from baseline till the end of study
Other outcomes:
Locations:
city: Saraland
country: United States
facility: Investigator Site - Saraland
state: Alabama
city: Phoenix
country: United States
facility: Investigator Site - Phoenix
state: Arizona
city: Tempe
country: United States
facility: Investigator Site - Tempe
state: Arizona
city: Little Rock
country: United States
facility: Investigator Site - Little Rock
state: Arkansas
city: Stamford
country: United States
facility: Investigator Site - Stamford
state: Connecticut
city: Clearwater
country: United States
facility: Investigator Site - Clearwater
state: Florida
city: Fort Lauderdale
country: United States
facility: Investigator Site - Fort Lauderdale
state: Florida
city: Fort Myers
country: United States
facility: Investigator Site - Fort Myers
state: Florida
city: Jacksonville
country: United States
facility: Investigator Site - Jacksonville
state: Florida
city: Orlando
country: United States
facility: Investigator Site - Orlando
state: Florida
city: Ormond Beach
country: United States
facility: Investigator Site - Ormond Beach
state: Florida
city: Plantation
country: United States
facility: Investigator Site - Plantation
state: Florida
city: Tampa
country: United States
facility: Investigator Site - Tampa
state: Florida
city: West Palm Beach
country: United States
facility: Investigator Site - West Palm Beach
state: Florida
city: Atlanta
country: United States
facility: Investigator Site - Atlanta
state: Georgia
city: Blue Ridge
country: United States
facility: Investigator Site - Blue Ridge
state: Georgia
city: Marietta
country: United States
facility: Investigator Site - Marietta
state: Georgia
city: Norcross
country: United States
facility: Investigator Site - Norcross
state: Georgia
city: Gurnee
country: United States
facility: Investigator Site - Gurnee
state: Illinois
city: West Des Moines
country: United States
facility: Investigator Site - West Des Moines
state: Iowa
city: Wichita
country: United States
facility: Investigator Site - Wichita
state: Kansas
city: Louisville
country: United States
facility: Investigator Site - Louisville
state: Kentucky
city: Bossier City
country: United States
facility: Investigator Site - Bossier
state: Louisiana
city: New Orleans
country: United States
facility: Investigator Site - New Orleans
state: Louisiana
city: Shreveport
country: United States
facility: Investigator Site - Shreveport
state: Louisiana
city: Bay City
country: United States
facility: Investigator Site - Bay City
state: Michigan
city: Pinconning
country: United States
facility: Investigator Site - Pinconning
state: Michigan
city: Biloxi
country: United States
facility: Investigator Site - Biloxi
state: Mississippi
city: Saint Louis
country: United States
facility: Investigator Site - Saint Louis 1
state: Missouri
city: Saint Louis
country: United States
facility: Investigator Site - Saint Louis 2
state: Missouri
city: Omaha
country: United States
facility: Investigator Site - Omaha
state: Nebraska
city: Las Vegas
country: United States
facility: Investigator Site - Las Vegas 2
state: Nevada
city: Las Vegas
country: United States
facility: Investigator Site - Las Vegas 1
state: Nevada
city: Rochester
country: United States
facility: Investigator Site - Rochester
state: New York
city: Williamsville
country: United States
facility: Investigator Site - Williamsville
state: New York
city: Greensboro
country: United States
facility: Investigator Site - Greensboro
state: North Carolina
city: Winston-Salem
country: United States
facility: Investigator Site - Winston Salem
state: North Carolina
city: Fargo
country: United States
facility: Investigator Site - Fargo
state: North Dakota
city: Beavercreek
country: United States
facility: Investigator Site - Beavercreek
state: Ohio
city: Cincinnati
country: United States
facility: Investigator Site - Cincinnati 1
state: Ohio
city: Cincinnati
country: United States
facility: Investigator Site - Cincinnati 2
state: Ohio
city: Columbus
country: United States
facility: Investigator Site - Columbus
state: Ohio
city: Duncansville
country: United States
facility: Investigator Site - Duncansville
state: Pennsylvania
city: Jenkintown
country: United States
facility: Investigator Site - Jenkintown
state: Pennsylvania
city: Dakota Dunes
country: United States
facility: Investigator Site - Dakota Dunes
state: South Dakota
city: Rapid City
country: United States
facility: Investigator Site - Rapid City
state: South Dakota
city: Memphis
country: United States
facility: Investigator Site - Memphis
state: Tennessee
city: Arlington
country: United States
facility: Investigator Site - Arlington
state: Texas
city: Austin
country: United States
facility: Investigator Site - Austin
state: Texas
city: Killeen
country: United States
facility: Investigator Site - Killeen
state: Texas
city: San Antonio
country: United States
facility: Investigator Site - San Antonio
state: Texas
city: Salt Lake City
country: United States
facility: Investigator Site - Salt Lake City
state: Utah
city: West Jordan
country: United States
facility: Investigator Site - West Jordan
state: Utah
city: Midlothian
country: United States
facility: Investigator Site - Midlothian
state: Virginia
city: Norfolk
country: United States
facility: Investigator Site - Norfolk
state: Virginia
city: Kenosha
country: United States
facility: Investigator Site - Kenosha
state: Wisconsin
Study officials:
References:
citation: Gudin J, Rauck R, Argoff C, Agaiby E, Gimbel J, Katz N, Doberstein SK, Tagliaferri M, Tagliaferri M, Potts J, Wild J, Lu L, Siddhanti S, Hale M, Markman J. Long-term Safety and Tolerability of NKTR-181 in Patients with Moderate to Severe Chronic Low Back Pain or Chronic Noncancer Pain: A Phase 3 Multicenter, Open-Label, 52-Week Study (SUMMIT-08 LTS). Pain Med. 2020 Nov 7;21(7):1347-1356. doi: 10.1093/pm/pnz169.
citation: Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.