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Low Back PainPhase 3SUMMIT-LTSNCT02367820

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

A Phase 3 study testing NKTR-181 BID tablets in people with Low Back Pain and Chronic Pain, run by Nektar Therapeutics at 56 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Low Back Pain, Chronic Pain
What is being tested?
NKTR-181 BID tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
638 participants
Where
56 sitesUnited States
Study dates
14 Apr 2015to Jan 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

56 sites in 1 country.

56 sites in 1 country

United States56 sites

  • Investigator Site - Arlington

    Arlington, Texas, 76012

  • Investigator Site - Atlanta

    Atlanta, Georgia, 30338

  • Investigator Site - Austin

    Austin, Texas, 78731

  • Investigator Site - Bay City

    Bay City, Michigan, 48706

  • Investigator Site - Beavercreek

    Beavercreek, Ohio, 45432

  • Investigator Site - Biloxi

    Biloxi, Mississippi, 39531

  • Investigator Site - Blue Ridge

    Blue Ridge, Georgia, 30513

  • Investigator Site - Bossier

    Bossier City, Louisiana, 71111

  • Investigator Site - Cincinnati 1

    Cincinnati, Ohio, 45219

  • Investigator Site - Cincinnati 2

    Cincinnati, Ohio, 45246

  • Investigator Site - Clearwater

    Clearwater, Florida, 33765

  • Investigator Site - Columbus

    Columbus, Ohio, 43235

  • Investigator Site - Dakota Dunes

    Dakota Dunes, South Dakota, 57047

  • Investigator Site - Duncansville

    Duncansville, Pennsylvania, 16635

  • Investigator Site - Fargo

    Fargo, North Dakota, 58104

  • Investigator Site - Fort Lauderdale

    Fort Lauderdale, Florida, 33312

  • Investigator Site - Fort Myers

    Fort Myers, Florida, 33912

  • Investigator Site - Greensboro

    Greensboro, North Carolina, 27410

  • Investigator Site - Gurnee

    Gurnee, Illinois, 60031

  • Investigator Site - Jacksonville

    Jacksonville, Florida, 32257

  • Investigator Site - Jenkintown

    Jenkintown, Pennsylvania, 19046

  • Investigator Site - Kenosha

    Kenosha, Wisconsin, 53142

  • Investigator Site - Killeen

    Killeen, Texas, 76543

  • Investigator Site - Las Vegas 2

    Las Vegas, Nevada, 89102

  • Investigator Site - Las Vegas 1

    Las Vegas, Nevada, 89119

  • Investigator Site - Little Rock

    Little Rock, Arkansas, 72211

  • Investigator Site - Louisville

    Louisville, Kentucky, 40213

  • Investigator Site - Marietta

    Marietta, Georgia, 30060

  • Investigator Site - Memphis

    Memphis, Tennessee, 38119

  • Investigator Site - Midlothian

    Midlothian, Virginia, 23114

  • Investigator Site - New Orleans

    New Orleans, Louisiana, 70115

  • Investigator Site - Norcross

    Norcross, Georgia, 30092

  • Investigator Site - Norfolk

    Norfolk, Virginia, 23507

  • Investigator Site - Omaha

    Omaha, Nebraska, 68134

  • Investigator Site - Orlando

    Orlando, Florida, 32806

  • Investigator Site - Ormond Beach

    Ormond Beach, Florida, 32174

  • Investigator Site - Phoenix

    Phoenix, Arizona, 85023

  • Investigator Site - Pinconning

    Pinconning, Michigan, 48706

  • Investigator Site - Plantation

    Plantation, Florida, 33324

  • Investigator Site - Rapid City

    Rapid City, South Dakota, 57702

  • Investigator Site - Rochester

    Rochester, New York, 14642

  • Investigator Site - Salt Lake City

    Salt Lake City, Utah, 84124

  • Investigator Site - San Antonio

    San Antonio, Texas, 78229

  • Investigator Site - Saraland

    Saraland, Alabama, 36571

  • Investigator Site - Shreveport

    Shreveport, Louisiana, 71105

  • Investigator Site - Saint Louis 1

    St Louis, Missouri, 63141

  • Investigator Site - Saint Louis 2

    St Louis, Missouri, 63141

  • Investigator Site - Stamford

    Stamford, Connecticut, 06905

  • Investigator Site - Tampa

    Tampa, Florida, 33603

  • Investigator Site - Tempe

    Tempe, Arizona, 85283

  • Investigator Site - West Des Moines

    West Des Moines, Iowa, 50265

  • Investigator Site - West Jordan

    West Jordan, Utah, 84088

  • Investigator Site - West Palm Beach

    West Palm Beach, Florida, 33409

  • Investigator Site - Wichita

    Wichita, Kansas, 67207

  • Investigator Site - Williamsville

    Williamsville, New York, 14221

  • Investigator Site - Winston Salem

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
NKTR-181 BID tablets
Medical subject headings
Low Back Pain, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NKTR-181 BID tabletsDrug

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

Study groups in NCT02367820
Study groupRoleWhat they receive
NKTR-181ExperimentalNKTR-181 twice daily (BID) tablets
Receives: Drug: NKTR-181 BID tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Reporting Adverse Events

    Count of subjects reporting treatment emergent adverse events

    Measured: Screening baseline through end of study, an average of 57 weeks

Secondary outcomes (2)

  1. 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.

    Measured: Baseline, monthly change from baseline till the end of study

  2. 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.

    Measured: Baseline, monthly change from baseline till the end of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2015 (estimated)
  2. Study start14 Apr 2015
  3. Primary completionDec 2017
  4. Study completionJan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
638 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02367820
Sponsor's protocol ID
14-181-08
Acronym
SUMMIT-LTS
Status last verified
Jun 2021
First submitted
9 Feb 2015
Last updated
22 Jun 2021
Data monitoring committee
No

Publications

  • 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.

    PubMed 31361019

  • 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.

    PubMed 30957581

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NKTR-181 BID tablets in people with Low Back Pain and Chronic Pain, run by Nektar Therapeutics at 56 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Reporting Adverse Events (time frame: Screening baseline through end of study, an average of 57 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02367820, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2021.

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