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Low Back PainPhase 3SUMMIT-07NCT02362672

Efficacy and Safety Study of NKTR-181 in Opioid-Naive Subjects With Low Back Pain

A Phase 3 study testing NKTR-181 BID tablets in people with Low Back Pain and Chronic Pain, run by Nektar Therapeutics at 54 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 study is to determine whether a new opioid molecule, NKTR-181, is effective for the relief of moderate to severe chronic low back pain as compared to a placebo. 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?
Yes, some participants may receive a placebo
How many people
1,189 participants
Where
54 sitesUnited States
Study dates
11 Mar 2015to Feb 2017
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 non-neuropathic low back pain for at least six months
  • Not experiencing adequate pain relief or have failed previous treatment with non-opioid analgesics
  • Opioid analgesia is necessary
  • Currently taking no more than 10 mg morphine sulfate equivalents per day of short acting opioids for 14 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

  • Taking extended release or long-acting opioids within 6 months
  • History of hypersensitivity, intolerance, or allergy to opioids
  • Compression of spinal nerve root; spinal fracture, tumor, or abscess
  • Surgical procedures on the low back in the last 12 months or facet nerve root block or radiofrequency ablation in the last 3 months
  • Untreated moderate to severe sleep apnea

Trial locations and contacts

54 sites in 1 country.

54 sites in 1 country

United States54 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 - Duncansville

    Duncansville, Pennsylvania, 16635

  • Investigator Site - Fargo

    Fargo, North Dakota, 58104

  • Investigator Site - Fort Lauderdale

    Fort Lauderdale, Florida, 33312

  • 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 Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of NKTR-181 in Opioid-Naive Subjects With Moderate to Severe Chronic Low Back Pain

The purpose of this study is to determine whether a new opioid molecule, NKTR-181, is effective for the relief of moderate to severe chronic low back pain as compared to a placebo.

Read the detailed description

This is an enriched enrollment, randomized withdrawal study with an open label, dose-titration period followed by a randomized, double-blind, placebo-control treatment of twelve weeks. During the double-blind treatment period, this study will evaluate the analgesic effect of NKTR-181 versus placebo in patients with moderate to severe chronic low back pain.

Being tested
NKTR-181 BID tablets, Placebo to match 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 100-400 mg twice daily (BID)

  • Placebo to match NKTR-181 BID tabletsDrug

    Placebo to match NKTR-181 tablets 100-400 mg twice daily (BID)

Study groups in NCT02362672
Study groupRoleWhat they receive
NKTR-181ExperimentalNKTR-181 twice daily (BID) tablets
Receives: Drug: NKTR-181 BID tablets
PlaceboPlacebo comparatorPlacebo to match NKTR-181 twice daily (BID) tablets
Receives: Drug: Placebo to match NKTR-181 BID tablets

What is being measured

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

  1. The Change in Weekly (ie, 7-day Average) Pain Score at the End of Double-blind, Randomized Treatment Period, Relative to the Weekly Score at the End of Titration (Double-blind Baseline)

    The daily pain intensity is an 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain).

    Measured: 12 Weeks of randomized double blinded period

Secondary outcomes (5)

  1. Responder Analysis Based on Percent Reduction in Pain Intensity

    A responder is defined by the Sponsor as a randomized subject who completes the double-blind Randomized Treatment Period and experiences improvement in the Week 12 Weekly Pain Score from Screening Pain Score. This includes the proportion of responders with at least 30% and at least 50% reduction in pain intensity.

    Measured: Screening Baseline through Week 12

  2. Patient Global Impression of Change (PGIC): Number of Responders

    The PGIC assesses the change in overall status relative to the initiation of the treatment. The scale measures global change of overall status on a 7-point scale (1 = No change (or condition has got worse), 2 = Almost the same, 3 = A little better, 4 = Somewhat better, 5 = Moderately better, 6 = Better, 7 = A great deal better). The proportion of subjects responding " A great deal better " and "better" was summarized by treatment group.

    Measured: Screening Baseline through Week 12

  3. Change in Sleep Quality in the Medical Outcome Study Sleep Scale - Revised (MOS Sleep-R)

    The MOS Sleep Scale measure sleep parameters contains 12 items. Eleven of them scored using a 5-point response scale and across 5 dimensions of sleep, including disturbance (4 items), sleep problems index (9 items), somnolence (3 items), adequacy (2 items), and respiratory impairments (2 items). The original survey items are converted to a 0 to 100 range (by Converting 1 to 0, 2 to 25, 3 to 50, 4 to 75, and 5 to 100). Items in each dimension (disturbance, sleep problems index, somnolence, adequacy, respiratory impairments) of sleep are averaged together to create the score for the scale. The range of each sleep dimension is from 0 to 100. Higher score of sleep disturbance, somnolence, sleep indices, and respiratory impairments indicates relatively worse sleep problem, whereas lower scores for sleep adequacy indicate worse sleep problems.

    Measured: Screening Baseline through Week 12

  4. Change in Sleep Quantity Measure in Hours in the Medical Outcome Study Sleep Scale - Revised (MOS Sleep-R)

    The 12 items of the MOS Sleep Scale measure sleep parameters across 6 dimensions of sleep, including disturbance (4 items), sleep problems index (9 items), quantity (1 item), somnolence (3 items), adequacy (2 items), and respiratory impairments (2 items). One of the 12 items, Sleep quantity, records the actual number of hours slept. Reported here is the sleep quantity.

    Measured: Screening Baseline through Week 12

  5. Change in Roland Morris Disability Questionnaire (RMDQ)

    The RMDQ contains 24 items that is used to quantify the impact of low back pain on subject's ability to perform daily activities, mood and sleep. The questionnaire consists of 24 statements derived from the Sickness Impact Profile, with the addition of the phrase "because of my back." The questionnaire covers the areas of mobility, self-care, and sleeping.

    The RMDQ score is the total number of items checked which is from a minimum of 0 to a maximum of 24; the greater the score the grater the physical disability due to lower back pain.

    Measured: Screening Baseline through Week 12

Timeline

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

  1. First posted13 Feb 2015 (estimated)
  2. Study start11 Mar 2015
  3. Primary completionDec 2016
  4. Study completionFeb 2017

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,189 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02362672
Sponsor's protocol ID
14-181-07
Acronym
SUMMIT-07
Status last verified
Sep 2020
First submitted
9 Feb 2015
Last updated
16 Sep 2020
Data monitoring committee
No

Publications

  • Markman J, Gudin J, Rauck R, Argoff C, Rowbotham M, Agaiby E, Gimbel J, Katz N, Doberstein SK, Tagliaferri M, Lu L, Siddhanti S, Hale M. SUMMIT-07: a randomized trial of NKTR-181, a new molecular entity, full mu-opioid receptor agonist for chronic low-back pain. Pain. 2019 Jun;160(6):1374-1382. doi: 10.1097/j.pain.0000000000001517.

    PubMed 30747908

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 54 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 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 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. Some participants in this study may receive a placebo. 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 16 Sep 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?

The Change in Weekly (ie, 7-day Average) Pain Score at the End of Double-blind, Randomized Treatment Period, Relative to the Weekly Score at the End of Titration (Double-blind Baseline) (time frame: 12 Weeks of randomized double blinded period). 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 NCT02362672, which also lists 1 linked publication.

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 16 Sep 2020.

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