MedDataX Logo

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

NCT ID: NCT02367820

Last Updated: 2021-06-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

638 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-14

Study Completion Date

2018-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP)

NCT00763321

Chronic Low Back Pain
COMPLETED PHASE3

Phase 2 Chronic Low Back Pain Study

NCT01364922

Chronic Low Back Pain
COMPLETED PHASE2

Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets for Moderate to Severe Chronic Low Back Pain

NCT01789970

Low Back Pain
COMPLETED PHASE3

Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP)

NCT00761150

Chronic Low Back Pain
COMPLETED PHASE3

Tapentadol Prolonged Release (PR) Versus Oxycodone/Naloxone Prolonged Release in Severe Chronic Low Back Pain With a Neuropathic Component.

NCT01838616

Back Pain Low Back Pain Neuropathic Pain
COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Low Back Pain Chronic Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

NKTR-181

NKTR-181 twice daily (BID) tablets

Group Type EXPERIMENTAL

NKTR-181 BID tablets

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

NKTR-181 BID tablets

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Nektar Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Investigator Site - Saraland

Saraland, Alabama, United States

Site Status

Investigator Site - Phoenix

Phoenix, Arizona, United States

Site Status

Investigator Site - Tempe

Tempe, Arizona, United States

Site Status

Investigator Site - Little Rock

Little Rock, Arkansas, United States

Site Status

Investigator Site - Stamford

Stamford, Connecticut, United States

Site Status

Investigator Site - Clearwater

Clearwater, Florida, United States

Site Status

Investigator Site - Fort Lauderdale

Fort Lauderdale, Florida, United States

Site Status

Investigator Site - Fort Myers

Fort Myers, Florida, United States

Site Status

Investigator Site - Jacksonville

Jacksonville, Florida, United States

Site Status

Investigator Site - Orlando

Orlando, Florida, United States

Site Status

Investigator Site - Ormond Beach

Ormond Beach, Florida, United States

Site Status

Investigator Site - Plantation

Plantation, Florida, United States

Site Status

Investigator Site - Tampa

Tampa, Florida, United States

Site Status

Investigator Site - West Palm Beach

West Palm Beach, Florida, United States

Site Status

Investigator Site - Atlanta

Atlanta, Georgia, United States

Site Status

Investigator Site - Blue Ridge

Blue Ridge, Georgia, United States

Site Status

Investigator Site - Marietta

Marietta, Georgia, United States

Site Status

Investigator Site - Norcross

Norcross, Georgia, United States

Site Status

Investigator Site - Gurnee

Gurnee, Illinois, United States

Site Status

Investigator Site - West Des Moines

West Des Moines, Iowa, United States

Site Status

Investigator Site - Wichita

Wichita, Kansas, United States

Site Status

Investigator Site - Louisville

Louisville, Kentucky, United States

Site Status

Investigator Site - Bossier

Bossier City, Louisiana, United States

Site Status

Investigator Site - New Orleans

New Orleans, Louisiana, United States

Site Status

Investigator Site - Shreveport

Shreveport, Louisiana, United States

Site Status

Investigator Site - Bay City

Bay City, Michigan, United States

Site Status

Investigator Site - Pinconning

Pinconning, Michigan, United States

Site Status

Investigator Site - Biloxi

Biloxi, Mississippi, United States

Site Status

Investigator Site - Saint Louis 1

St Louis, Missouri, United States

Site Status

Investigator Site - Saint Louis 2

St Louis, Missouri, United States

Site Status

Investigator Site - Omaha

Omaha, Nebraska, United States

Site Status

Investigator Site - Las Vegas 2

Las Vegas, Nevada, United States

Site Status

Investigator Site - Las Vegas 1

Las Vegas, Nevada, United States

Site Status

Investigator Site - Rochester

Rochester, New York, United States

Site Status

Investigator Site - Williamsville

Williamsville, New York, United States

Site Status

Investigator Site - Greensboro

Greensboro, North Carolina, United States

Site Status

Investigator Site - Winston Salem

Winston-Salem, North Carolina, United States

Site Status

Investigator Site - Fargo

Fargo, North Dakota, United States

Site Status

Investigator Site - Beavercreek

Beavercreek, Ohio, United States

Site Status

Investigator Site - Cincinnati 1

Cincinnati, Ohio, United States

Site Status

Investigator Site - Cincinnati 2

Cincinnati, Ohio, United States

Site Status

Investigator Site - Columbus

Columbus, Ohio, United States

Site Status

Investigator Site - Duncansville

Duncansville, Pennsylvania, United States

Site Status

Investigator Site - Jenkintown

Jenkintown, Pennsylvania, United States

Site Status

Investigator Site - Dakota Dunes

Dakota Dunes, South Dakota, United States

Site Status

Investigator Site - Rapid City

Rapid City, South Dakota, United States

Site Status

Investigator Site - Memphis

Memphis, Tennessee, United States

Site Status

Investigator Site - Arlington

Arlington, Texas, United States

Site Status

Investigator Site - Austin

Austin, Texas, United States

Site Status

Investigator Site - Killeen

Killeen, Texas, United States

Site Status

Investigator Site - San Antonio

San Antonio, Texas, United States

Site Status

Investigator Site - Salt Lake City

Salt Lake City, Utah, United States

Site Status

Investigator Site - West Jordan

West Jordan, Utah, United States

Site Status

Investigator Site - Midlothian

Midlothian, Virginia, United States

Site Status

Investigator Site - Norfolk

Norfolk, Virginia, United States

Site Status

Investigator Site - Kenosha

Kenosha, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 31361019 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30957581 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

14-181-08

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

NUCYNTA (Tapentadol Immediate Release) Versus Oxycodone Immediate Release in the Treatment of Acute Low Back Pain
NCT00986180 COMPLETED PHASE3
A Study to Compare Oxycodone/Naloxone Prolonged Release Against Codeine/Paracetamol in the Treatment of Moderate to Severe Chronic Low Back Pain or Pain Due to Osteoarthritis
NCT00784810 COMPLETED PHASE4
Phase 3 Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Low Back Pain
NCT01081912 COMPLETED PHASE3
Bioequivalence Study Comparing Naltrexone SR/Bupropion SR Trilayer Tablets From Two Manufacturers
NCT02259179 COMPLETED PHASE1
Long-term Safety of PF-00345439 (Oxycodone)
NCT01559701 COMPLETED PHASE3
A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) Extended Release (ER) in Patients With Moderate to Severe Chronic Low Back Pain
NCT00449176 COMPLETED PHASE3
A Comparison of Plasma Concentrations of Hydrocodone and Acetaminophen After Administration of Different Amounts of Tablets of a New and a Marketed Tablet Formulation in Healthy Adults
NCT03137030 WITHDRAWN PHASE1
A Study of Pain Relief in Low Back Pain
NCT00325949 COMPLETED PHASE3
Celebrex vs Tramadol in the Treatment of Chronic Lower Back Pain.
NCT00290901 COMPLETED PHASE4
Safety and Tolerability of Egalet-002 in Patients With Moderate-to-Severe Chronic Noncancer Pain
NCT02603705 COMPLETED PHASE3
An Open-label Evaluation of Tapentadol Extended Release (ER) in Participants With Moderate to Severe Chronic Pain After Conversion From Hydrocodone, Oxycodone Controlled Release (CR), and/or Morphine Sustained Release (SR)
NCT01631513 WITHDRAWN PHASE4
A Study to Evaluate Long-Term Safety of Multiple Doses of Tapentadol (CG5503) Prolonged-Release (PR) and Oxycodone Controlled-Release (CR) in Patients With Chronic Pain
NCT00361504 COMPLETED PHASE3
To Evaluate the Relative Abuse Potential of Hydrocodone Bitartrate and Acetaminophen
NCT03567941 COMPLETED PHASE1
OTR Tablet 10 mg Fasted-state Bioequivalence Study
NCT03403504 COMPLETED PHASE1
A Comparison of Plasma Concentrations of Hydrocodone and Acetaminophen After Administration of a New and a Marketed Tablet Formulation Under Fasted and Fed Conditions in Healthy Adults
NCT03137017 WITHDRAWN PHASE1
Open-Label, Extension Study to Evaluate the Safety of Hydrocodone Bitartrate Extended-Release Tablets
NCT01922739 COMPLETED PHASE3
To Determine the Fed Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets
NCT01101178 COMPLETED PHASE1
Bioavailability of Oxymorphone Hydrochloride 40 mg Extended Release Tablets Under Fed Conditions
NCT00857142 COMPLETED PHASE1
A Study to Evaluate the Relative Bioavailability and Food Effect of a New Tablet Formulation of VX-548
NCT05455502 COMPLETED PHASE1
Efficacy and Safety of Egalet-002 in Patients With Moderate-to-Severe Chronic Low Back Pain
NCT02716857 COMPLETED PHASE3
A Randomized, Two-way, Crossover Study to Estimate the Relative Bioavailability of a Controlled-release Formulation of Oxycodone (40 mg) With Sequestered Naltrexone Compared With Immediate-release Oxycodone Tablets (20 mg) in Healthy Volunteers
NCT01677065 COMPLETED
Oxycodone DETERx™ Versus Placebo in Chronic Low Back Pain (CLBP)
NCT01685684 COMPLETED PHASE3
Bioequivalence Trial of a New Opioid Combination Compared to Reference
NCT00460785 COMPLETED PHASE1
Study to Evaluate the Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) for Relief of Moderate to Severe Pain in Patients With Osteoarthritis or Low Back Pain Who Require Opioid Treatment for an Extended Period of Time
NCT01240863 COMPLETED PHASE3
OTR Tablet 40 mg Fed-state Bioequivalence Study
NCT03398330 COMPLETED PHASE1