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

Primary Purpose

Low Back Pain, Chronic Pain

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
NKTR-181 BID tablets
Sponsored by
Nektar Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Investigator Site - Saraland
  • Investigator Site - Phoenix
  • Investigator Site - Tempe
  • Investigator Site - Little Rock
  • Investigator Site - Stamford
  • Investigator Site - Clearwater
  • Investigator Site - Fort Lauderdale
  • Investigator Site - Fort Myers
  • Investigator Site - Jacksonville
  • Investigator Site - Orlando
  • Investigator Site - Ormond Beach
  • Investigator Site - Plantation
  • Investigator Site - Tampa
  • Investigator Site - West Palm Beach
  • Investigator Site - Atlanta
  • Investigator Site - Blue Ridge
  • Investigator Site - Marietta
  • Investigator Site - Norcross
  • Investigator Site - Gurnee
  • Investigator Site - West Des Moines
  • Investigator Site - Wichita
  • Investigator Site - Louisville
  • Investigator Site - Bossier
  • Investigator Site - New Orleans
  • Investigator Site - Shreveport
  • Investigator Site - Bay City
  • Investigator Site - Pinconning
  • Investigator Site - Biloxi
  • Investigator Site - Saint Louis 1
  • Investigator Site - Saint Louis 2
  • Investigator Site - Omaha
  • Investigator Site - Las Vegas 2
  • Investigator Site - Las Vegas 1
  • Investigator Site - Rochester
  • Investigator Site - Williamsville
  • Investigator Site - Greensboro
  • Investigator Site - Winston Salem
  • Investigator Site - Fargo
  • Investigator Site - Beavercreek
  • Investigator Site - Cincinnati 1
  • Investigator Site - Cincinnati 2
  • Investigator Site - Columbus
  • Investigator Site - Duncansville
  • Investigator Site - Jenkintown
  • Investigator Site - Dakota Dunes
  • Investigator Site - Rapid City
  • Investigator Site - Memphis
  • Investigator Site - Arlington
  • Investigator Site - Austin
  • Investigator Site - Killeen
  • Investigator Site - San Antonio
  • Investigator Site - Salt Lake City
  • Investigator Site - West Jordan
  • Investigator Site - Midlothian
  • Investigator Site - Norfolk
  • Investigator Site - Kenosha

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NKTR-181

Arm Description

NKTR-181 twice daily (BID) tablets

Outcomes

Primary Outcome Measures

Number of Participants Reporting Adverse Events
Count of subjects reporting treatment emergent adverse events

Secondary Outcome Measures

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.
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.

Full Information

First Posted
February 9, 2015
Last Updated
June 15, 2021
Sponsor
Nektar Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT02367820
Brief Title
Long-Term Safety and Tolerability Study of NKTR-181 in Subjects With Chronic Low Back Pain or Chronic Non-Cancer Pain
Acronym
SUMMIT-LTS
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

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
April 14, 2015 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nektar Therapeutics

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Chronic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
638 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NKTR-181
Arm Type
Experimental
Arm Description
NKTR-181 twice daily (BID) tablets
Intervention Type
Drug
Intervention Name(s)
NKTR-181 BID tablets
Intervention Description
NKTR-181 tablets 100-600 mg twice daily (BID)
Primary Outcome Measure Information:
Title
Number of Participants Reporting Adverse Events
Description
Count of subjects reporting treatment emergent adverse events
Time Frame
Screening baseline through end of study, an average of 57 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52
Description
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.
Time Frame
Baseline, monthly change from baseline till the end of study
Title
Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52
Description
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.
Time Frame
Baseline, monthly change from baseline till the end of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Investigator Site - Saraland
City
Saraland
State/Province
Alabama
ZIP/Postal Code
36571
Country
United States
Facility Name
Investigator Site - Phoenix
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Investigator Site - Tempe
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
Facility Name
Investigator Site - Little Rock
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Investigator Site - Stamford
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
Investigator Site - Clearwater
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Investigator Site - Fort Lauderdale
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33312
Country
United States
Facility Name
Investigator Site - Fort Myers
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Investigator Site - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32257
Country
United States
Facility Name
Investigator Site - Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Investigator Site - Ormond Beach
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Investigator Site - Plantation
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Investigator Site - Tampa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Investigator Site - West Palm Beach
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Investigator Site - Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
Facility Name
Investigator Site - Blue Ridge
City
Blue Ridge
State/Province
Georgia
ZIP/Postal Code
30513
Country
United States
Facility Name
Investigator Site - Marietta
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Investigator Site - Norcross
City
Norcross
State/Province
Georgia
ZIP/Postal Code
30092
Country
United States
Facility Name
Investigator Site - Gurnee
City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60031
Country
United States
Facility Name
Investigator Site - West Des Moines
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
Investigator Site - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Investigator Site - Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Investigator Site - Bossier
City
Bossier City
State/Province
Louisiana
ZIP/Postal Code
71111
Country
United States
Facility Name
Investigator Site - New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Investigator Site - Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Facility Name
Investigator Site - Bay City
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48706
Country
United States
Facility Name
Investigator Site - Pinconning
City
Pinconning
State/Province
Michigan
ZIP/Postal Code
48706
Country
United States
Facility Name
Investigator Site - Biloxi
City
Biloxi
State/Province
Mississippi
ZIP/Postal Code
39531
Country
United States
Facility Name
Investigator Site - Saint Louis 1
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Investigator Site - Saint Louis 2
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Investigator Site - Omaha
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Investigator Site - Las Vegas 2
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Investigator Site - Las Vegas 1
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Investigator Site - Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Investigator Site - Williamsville
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Investigator Site - Greensboro
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27410
Country
United States
Facility Name
Investigator Site - Winston Salem
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Investigator Site - Fargo
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
Investigator Site - Beavercreek
City
Beavercreek
State/Province
Ohio
ZIP/Postal Code
45432
Country
United States
Facility Name
Investigator Site - Cincinnati 1
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Investigator Site - Cincinnati 2
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45246
Country
United States
Facility Name
Investigator Site - Columbus
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
Investigator Site - Duncansville
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Investigator Site - Jenkintown
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Investigator Site - Dakota Dunes
City
Dakota Dunes
State/Province
South Dakota
ZIP/Postal Code
57047
Country
United States
Facility Name
Investigator Site - Rapid City
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
Investigator Site - Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Investigator Site - Arlington
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Investigator Site - Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Investigator Site - Killeen
City
Killeen
State/Province
Texas
ZIP/Postal Code
76543
Country
United States
Facility Name
Investigator Site - San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Investigator Site - Salt Lake City
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Investigator Site - West Jordan
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Investigator Site - Midlothian
City
Midlothian
State/Province
Virginia
ZIP/Postal Code
23114
Country
United States
Facility Name
Investigator Site - Norfolk
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Investigator Site - Kenosha
City
Kenosha
State/Province
Wisconsin
ZIP/Postal Code
53142
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31361019
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.
Results Reference
background
PubMed Identifier
30957581
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.
Results Reference
derived
Links:
URL
https://academic.oup.com/painmedicine/article/doi/10.1093/pm/pnz169/5540711
Description
Related Info

Learn more about this trial

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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