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

Chronic Pain Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02367820
• Other study ID #: 14-181-08
• Status: Completed
• Phase: Phase 3
• Start date: April 14, 2015
• Est. completion date: January 2018

Study information

• Verified date: June 2021
• Source: Nektar Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 638
• Est. completion date: January 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Pain
• Low Back Pain

Intervention

Drug:
• NKTR-181 BID tablets
NKTR-181 tablets 100-600 mg twice daily (BID)

Locations

Country	Name	City	State
United States	Investigator Site - Arlington	Arlington	Texas
United States	Investigator Site - Atlanta	Atlanta	Georgia
United States	Investigator Site - Austin	Austin	Texas
United States	Investigator Site - Bay City	Bay City	Michigan
United States	Investigator Site - Beavercreek	Beavercreek	Ohio
United States	Investigator Site - Biloxi	Biloxi	Mississippi
United States	Investigator Site - Blue Ridge	Blue Ridge	Georgia
United States	Investigator Site - Bossier	Bossier City	Louisiana
United States	Investigator Site - Cincinnati 1	Cincinnati	Ohio
United States	Investigator Site - Cincinnati 2	Cincinnati	Ohio
United States	Investigator Site - Clearwater	Clearwater	Florida
United States	Investigator Site - Columbus	Columbus	Ohio
United States	Investigator Site - Dakota Dunes	Dakota Dunes	South Dakota
United States	Investigator Site - Duncansville	Duncansville	Pennsylvania
United States	Investigator Site - Fargo	Fargo	North Dakota
United States	Investigator Site - Fort Lauderdale	Fort Lauderdale	Florida
United States	Investigator Site - Fort Myers	Fort Myers	Florida
United States	Investigator Site - Greensboro	Greensboro	North Carolina
United States	Investigator Site - Gurnee	Gurnee	Illinois
United States	Investigator Site - Jacksonville	Jacksonville	Florida
United States	Investigator Site - Jenkintown	Jenkintown	Pennsylvania
United States	Investigator Site - Kenosha	Kenosha	Wisconsin
United States	Investigator Site - Killeen	Killeen	Texas
United States	Investigator Site - Las Vegas 1	Las Vegas	Nevada
United States	Investigator Site - Las Vegas 2	Las Vegas	Nevada
United States	Investigator Site - Little Rock	Little Rock	Arkansas
United States	Investigator Site - Louisville	Louisville	Kentucky
United States	Investigator Site - Marietta	Marietta	Georgia
United States	Investigator Site - Memphis	Memphis	Tennessee
United States	Investigator Site - Midlothian	Midlothian	Virginia
United States	Investigator Site - New Orleans	New Orleans	Louisiana
United States	Investigator Site - Norcross	Norcross	Georgia
United States	Investigator Site - Norfolk	Norfolk	Virginia
United States	Investigator Site - Omaha	Omaha	Nebraska
United States	Investigator Site - Orlando	Orlando	Florida
United States	Investigator Site - Ormond Beach	Ormond Beach	Florida
United States	Investigator Site - Phoenix	Phoenix	Arizona
United States	Investigator Site - Pinconning	Pinconning	Michigan
United States	Investigator Site - Plantation	Plantation	Florida
United States	Investigator Site - Rapid City	Rapid City	South Dakota
United States	Investigator Site - Rochester	Rochester	New York
United States	Investigator Site - Saint Louis 1	Saint Louis	Missouri
United States	Investigator Site - Saint Louis 2	Saint Louis	Missouri
United States	Investigator Site - Salt Lake City	Salt Lake City	Utah
United States	Investigator Site - San Antonio	San Antonio	Texas
United States	Investigator Site - Saraland	Saraland	Alabama
United States	Investigator Site - Shreveport	Shreveport	Louisiana
United States	Investigator Site - Stamford	Stamford	Connecticut
United States	Investigator Site - Tampa	Tampa	Florida
United States	Investigator Site - Tempe	Tempe	Arizona
United States	Investigator Site - West Des Moines	West Des Moines	Iowa
United States	Investigator Site - West Jordan	West Jordan	Utah
United States	Investigator Site - West Palm Beach	West Palm Beach	Florida
United States	Investigator Site - Wichita	Wichita	Kansas
United States	Investigator Site - Williamsville	Williamsville	New York
United States	Investigator Site - Winston Salem	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Nektar Therapeutics

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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

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