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

NCT02367820 | Completed Phase 3 Results

• 1 other identifier: 14-181-08
• Study Type: interventional
• Target: 638
• Locations: 1 country
• Sites: 56

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.

Conditions

Low Back Pain; Chronic Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52

  Baseline, monthly change from baseline till the end of study

• Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52

  Baseline, monthly change from baseline till the end of study

Study Arms (1)

NKTR-181

EXPERIMENTAL

NKTR-181 twice daily (BID) tablets

Drug: NKTR-181 BID tablets

Interventions

NKTR-181 BID tablets DRUG

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

NKTR-181

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nektar Therapeutics: lead

Study Sites (56)

Investigator Site - Saraland

Saraland, Alabama, 36571, United States

Location

Investigator Site - Phoenix

Phoenix, Arizona, 85023, United States

Location

Investigator Site - Tempe

Tempe, Arizona, 85283, United States

Location

Investigator Site - Little Rock

Little Rock, Arkansas, 72211, United States

Location

Investigator Site - Stamford

Stamford, Connecticut, 06905, United States

Location

Investigator Site - Clearwater

Clearwater, Florida, 33765, United States

Location

Investigator Site - Fort Lauderdale

Fort Lauderdale, Florida, 33312, United States

Location

Investigator Site - Fort Myers

Fort Myers, Florida, 33912, United States

Location

Investigator Site - Jacksonville

Jacksonville, Florida, 32257, United States

Location

Investigator Site - Orlando

Orlando, Florida, 32806, United States

Location

Investigator Site - Ormond Beach

Ormond Beach, Florida, 32174, United States

Location

Investigator Site - Plantation

Plantation, Florida, 33324, United States

Location

Investigator Site - Tampa

Tampa, Florida, 33603, United States

Location

Investigator Site - West Palm Beach

West Palm Beach, Florida, 33409, United States

Location

Investigator Site - Atlanta

Atlanta, Georgia, 30338, United States

Location

Investigator Site - Blue Ridge

Blue Ridge, Georgia, 30513, United States

Location

Investigator Site - Marietta

Marietta, Georgia, 30060, United States

Location

Investigator Site - Norcross

Norcross, Georgia, 30092, United States

Location

Investigator Site - Gurnee

Gurnee, Illinois, 60031, United States

Location

Investigator Site - West Des Moines

West Des Moines, Iowa, 50265, United States

Location

Investigator Site - Wichita

Wichita, Kansas, 67207, United States

Location

Investigator Site - Louisville

Louisville, Kentucky, 40213, United States

Location

Investigator Site - Bossier

Bossier City, Louisiana, 71111, United States

Location

Investigator Site - New Orleans

New Orleans, Louisiana, 70115, United States

Location

Investigator Site - Shreveport

Shreveport, Louisiana, 71105, United States

Location

Investigator Site - Bay City

Bay City, Michigan, 48706, United States

Location

Investigator Site - Pinconning

Pinconning, Michigan, 48706, United States

Location

Investigator Site - Biloxi

Biloxi, Mississippi, 39531, United States

Location

Investigator Site - Saint Louis 1

St Louis, Missouri, 63141, United States

Location

Investigator Site - Saint Louis 2

St Louis, Missouri, 63141, United States

Location

Investigator Site - Omaha

Omaha, Nebraska, 68134, United States

Location

Investigator Site - Las Vegas 2

Las Vegas, Nevada, 89102, United States

Location

Investigator Site - Las Vegas 1

Las Vegas, Nevada, 89119, United States

Location

Investigator Site - Rochester

Rochester, New York, 14642, United States

Location

Investigator Site - Williamsville

Williamsville, New York, 14221, United States

Location

Investigator Site - Greensboro

Greensboro, North Carolina, 27410, United States

Location

Investigator Site - Winston Salem

Winston-Salem, North Carolina, 27103, United States

Location

Investigator Site - Fargo

Fargo, North Dakota, 58104, United States

Location

Investigator Site - Beavercreek

Beavercreek, Ohio, 45432, United States

Location

Investigator Site - Cincinnati 1

Cincinnati, Ohio, 45219, United States

Location

Investigator Site - Cincinnati 2

Cincinnati, Ohio, 45246, United States

Location

Investigator Site - Columbus

Columbus, Ohio, 43235, United States

Location

Investigator Site - Duncansville

Duncansville, Pennsylvania, 16635, United States

Location

Investigator Site - Jenkintown

Jenkintown, Pennsylvania, 19046, United States

Location

Investigator Site - Dakota Dunes

Dakota Dunes, South Dakota, 57047, United States

Location

Investigator Site - Rapid City

Rapid City, South Dakota, 57702, United States

Location

Investigator Site - Memphis

Memphis, Tennessee, 38119, United States

Location

Investigator Site - Arlington

Arlington, Texas, 76012, United States

Location

Investigator Site - Austin

Austin, Texas, 78731, United States

Location

Investigator Site - Killeen

Killeen, Texas, 76543, United States

Location

Investigator Site - San Antonio

San Antonio, Texas, 78229, United States

Location

Investigator Site - Salt Lake City

Salt Lake City, Utah, 84124, United States

Location

Investigator Site - West Jordan

West Jordan, Utah, 84088, United States

Location

Investigator Site - Midlothian

Midlothian, Virginia, 23114, United States

Location

Investigator Site - Norfolk

Norfolk, Virginia, 23507, United States

Location

Investigator Site - Kenosha

Kenosha, Wisconsin, 53142, United States

Location

Related Publications (2)

• 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.

  PMID: 31361019 BACKGROUND

• 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.

  PMID: 30957581 DERIVED

MeSH Terms

Conditions

Low Back Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Medical Affairs
• Organization: Nektar Therapeutics

StudyInquiry@nektar.com

855-482-8676

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2015
• First Posted: February 20, 2015
• Study Start: April 14, 2015
• Primary Completion: December 1, 2017
• Study Completion: January 1, 2018
• Last Updated: June 22, 2021
• Results First Posted: October 8, 2020

Record last verified: 2021-06

Locations

US (56)