Long-Term Safety and Tolerability Study of NKTR-181 in Subjects With Chronic Low Back Pain or Chronic Non-Cancer Pain (SUMMIT-LTS)

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

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Chronic Pain
• Intervention / Treatment: Drug: NKTR-181 BID tablets

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.

• Study Type: Interventional
• Enrollment (Actual): 638
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Saraland, Alabama, United States, 36571
      • Investigator Site - Saraland
  • Arizona
    • Phoenix, Arizona, United States, 85023
      • Investigator Site - Phoenix
    • Tempe, Arizona, United States, 85283
      • Investigator Site - Tempe
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Investigator Site - Little Rock
  • Connecticut
    • Stamford, Connecticut, United States, 06905
      • Investigator Site - Stamford
  • Florida
    • Clearwater, Florida, United States, 33765
      • Investigator Site - Clearwater
    • Fort Lauderdale, Florida, United States, 33312
      • Investigator Site - Fort Lauderdale
    • Fort Myers, Florida, United States, 33912
      • Investigator Site - Fort Myers
    • Jacksonville, Florida, United States, 32257
      • Investigator Site - Jacksonville
    • Orlando, Florida, United States, 32806
      • Investigator Site - Orlando
    • Ormond Beach, Florida, United States, 32174
      • Investigator Site - Ormond Beach
    • Plantation, Florida, United States, 33324
      • Investigator Site - Plantation
    • Tampa, Florida, United States, 33603
      • Investigator Site - Tampa
    • West Palm Beach, Florida, United States, 33409
      • Investigator Site - West Palm Beach
  • Georgia
    • Atlanta, Georgia, United States, 30338
      • Investigator Site - Atlanta
    • Blue Ridge, Georgia, United States, 30513
      • Investigator Site - Blue Ridge
    • Marietta, Georgia, United States, 30060
      • Investigator Site - Marietta
    • Norcross, Georgia, United States, 30092
      • Investigator Site - Norcross
  • Illinois
    • Gurnee, Illinois, United States, 60031
      • Investigator Site - Gurnee
  • Iowa
    • West Des Moines, Iowa, United States, 50265
      • Investigator Site - West Des Moines
  • Kansas
    • Wichita, Kansas, United States, 67207
      • Investigator Site - Wichita
  • Kentucky
    • Louisville, Kentucky, United States, 40213
      • Investigator Site - Louisville
  • Louisiana
    • Bossier City, Louisiana, United States, 71111
      • Investigator Site - Bossier
    • New Orleans, Louisiana, United States, 70115
      • Investigator Site - New Orleans
    • Shreveport, Louisiana, United States, 71105
      • Investigator Site - Shreveport
  • Michigan
    • Bay City, Michigan, United States, 48706
      • Investigator Site - Bay City
    • Pinconning, Michigan, United States, 48706
      • Investigator Site - Pinconning
  • Mississippi
    • Biloxi, Mississippi, United States, 39531
      • Investigator Site - Biloxi
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Investigator Site - Saint Louis 1
    • Saint Louis, Missouri, United States, 63141
      • Investigator Site - Saint Louis 2
  • Nebraska
    • Omaha, Nebraska, United States, 68134
      • Investigator Site - Omaha
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Investigator Site - Las Vegas 2
    • Las Vegas, Nevada, United States, 89119
      • Investigator Site - Las Vegas 1
  • New York
    • Rochester, New York, United States, 14642
      • Investigator Site - Rochester
    • Williamsville, New York, United States, 14221
      • Investigator Site - Williamsville
  • North Carolina
    • Greensboro, North Carolina, United States, 27410
      • Investigator Site - Greensboro
    • Winston-Salem, North Carolina, United States, 27103
      • Investigator Site - Winston Salem
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Investigator Site - Fargo
  • Ohio
    • Beavercreek, Ohio, United States, 45432
      • Investigator Site - Beavercreek
    • Cincinnati, Ohio, United States, 45219
      • Investigator Site - Cincinnati 1
    • Cincinnati, Ohio, United States, 45246
      • Investigator Site - Cincinnati 2
    • Columbus, Ohio, United States, 43235
      • Investigator Site - Columbus
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Investigator Site - Duncansville
    • Jenkintown, Pennsylvania, United States, 19046
      • Investigator Site - Jenkintown
  • South Dakota
    • Dakota Dunes, South Dakota, United States, 57047
      • Investigator Site - Dakota Dunes
    • Rapid City, South Dakota, United States, 57702
      • Investigator Site - Rapid City
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Investigator Site - Memphis
  • Texas
    • Arlington, Texas, United States, 76012
      • Investigator Site - Arlington
    • Austin, Texas, United States, 78731
      • Investigator Site - Austin
    • Killeen, Texas, United States, 76543
      • Investigator Site - Killeen
    • San Antonio, Texas, United States, 78229
      • Investigator Site - San Antonio
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • Investigator Site - Salt Lake City
    • West Jordan, Utah, United States, 84088
      • Investigator Site - West Jordan
  • Virginia
    • Midlothian, Virginia, United States, 23114
      • Investigator Site - Midlothian
    • Norfolk, Virginia, United States, 23507
      • Investigator Site - Norfolk
  • Wisconsin
    • Kenosha, Wisconsin, United States, 53142
      • Investigator Site - Kenosha

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NKTR-181; NKTR-181 twice daily (BID) tablets	Drug: NKTR-181 BID tablets; NKTR-181 tablets 100-600 mg twice daily (BID)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Reporting Adverse Events	Count of subjects reporting treatment emergent adverse events	Screening baseline through end of study, an average of 57 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52	A self-reported scale measuring severity of pain on function. The mean of the 4 intensity items (3-6) is calculated and used as a measure of pain severity. If there were missing items when the pain severity score was calculated, the mean of the completed items in one dimension (dimensions include pain severity and pain interference) were imputed to substitute the missing item, provided that more than 50% of the items in one dimension were completed (Halling, 1999). The range of pain intensity and interference for each question is from 0 to 10. The range of possible scores is from 0 to 70. Higher score indicates relatively worse pain severity and greater interference that pain causes in day to day activities.	Baseline, monthly change from baseline till the end of study
Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52	A self-reported scale measuring interference of pain on function. The mean of the 7 interference items was calculated and used as a measure of Pain interference. If there were missing items when the pain interference score was calculated, the mean of the completed items in one dimension (dimensions include pain severity and pain interference) were imputed to substitute the missing item, provided that more than 50% of the items in one dimension were completed (Halling, 1999). The range of pain interference is from 0 to 10. Higher score indicates relatively worse pain problem.	Baseline, monthly change from baseline till the end of study

Collaborators and Investigators

• Sponsor: Nektar Therapeutics

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2015
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: February 9, 2015
• First Submitted That Met QC Criteria: February 13, 2015
• First Posted (Estimate): February 20, 2015

Study Record Updates

• Last Update Posted (Actual): June 22, 2021
• Last Update Submitted That Met QC Criteria: June 15, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Chronic Pain
• Other Study ID Numbers: 14-181-08