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

June 15, 2021 updated by: Nektar Therapeutics

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
638

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants Reporting Adverse Events
Time Frame: Screening baseline through end of study, an average of 57 weeks
Count of subjects reporting treatment emergent adverse events
Screening baseline through end of study, an average of 57 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52
Time Frame: Baseline, monthly change from baseline till the end of study
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
Time Frame: Baseline, monthly change from baseline till the end of study
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nektar Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 14, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 9, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 22, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 14-181-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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