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

NCT ID: NCT02362672

Last Updated: 2020-09-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1189 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-11

Study Completion Date

2017-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Low Back Pain Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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NKTR-181

NKTR-181 twice daily (BID) tablets

Group Type EXPERIMENTAL

NKTR-181 BID tablets

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo to match NKTR-181 BID tablets

Intervention Type DRUG

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

Interventions

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NKTR-181 BID tablets

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

Intervention Type DRUG

Placebo to match NKTR-181 BID tablets

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nektar Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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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

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Investigator Site - Little Rock

Little Rock, Arkansas, United States

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Investigator Site - Stamford

Stamford, Connecticut, United States

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Investigator Site - Clearwater

Clearwater, Florida, United States

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Investigator Site - Fort Lauderdale

Fort Lauderdale, Florida, United States

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Investigator Site - Jacksonville

Jacksonville, Florida, United States

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Investigator Site - Orlando

Orlando, Florida, United States

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Investigator Site - Ormond Beach

Ormond Beach, Florida, United States

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Investigator Site - Plantation

Plantation, Florida, United States

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Investigator Site - Tampa

Tampa, Florida, United States

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Investigator Site - West Palm Beach

West Palm Beach, Florida, United States

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Investigator Site - Atlanta

Atlanta, Georgia, United States

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Investigator Site - Blue Ridge

Blue Ridge, Georgia, United States

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Investigator Site - Marietta

Marietta, Georgia, United States

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Investigator Site - Norcross

Norcross, Georgia, United States

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Investigator Site - Gurnee

Gurnee, Illinois, United States

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Investigator Site - West Des Moines

West Des Moines, Iowa, United States

Site Status

Investigator Site - Wichita

Wichita, Kansas, United States

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Investigator Site - Louisville

Louisville, Kentucky, United States

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Investigator Site - Bossier

Bossier City, Louisiana, United States

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Investigator Site - New Orleans

New Orleans, Louisiana, United States

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Investigator Site - Shreveport

Shreveport, Louisiana, United States

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Investigator Site - Bay City

Bay City, Michigan, United States

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Investigator Site - Pinconning

Pinconning, Michigan, United States

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Investigator Site - Biloxi

Biloxi, Mississippi, United States

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Investigator Site - Saint Louis 1

St Louis, Missouri, United States

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Investigator Site - Saint Louis 2

St Louis, Missouri, United States

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Investigator Site - Omaha

Omaha, Nebraska, United States

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Investigator Site - Las Vegas 2

Las Vegas, Nevada, United States

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Investigator Site - Las Vegas 1

Las Vegas, Nevada, United States

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Investigator Site - Rochester

Rochester, New York, United States

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Investigator Site - Williamsville

Williamsville, New York, United States

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Investigator Site - Greensboro

Greensboro, North Carolina, United States

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Investigator Site - Winston Salem

Winston-Salem, North Carolina, United States

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Investigator Site - Fargo

Fargo, North Dakota, United States

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Investigator Site - Beavercreek

Beavercreek, Ohio, United States

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Investigator Site - Cincinnati 1

Cincinnati, Ohio, United States

Site Status

Investigator Site - Cincinnati 2

Cincinnati, Ohio, United States

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Investigator Site - Columbus

Columbus, Ohio, United States

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Investigator Site - Duncansville

Duncansville, Pennsylvania, United States

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Investigator Site - Jenkintown

Jenkintown, Pennsylvania, United States

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Investigator Site - Rapid City

Rapid City, South Dakota, United States

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Investigator Site - Memphis

Memphis, Tennessee, United States

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Investigator Site - Arlington

Arlington, Texas, United States

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Investigator Site - Austin

Austin, Texas, United States

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Investigator Site - Killeen

Killeen, Texas, United States

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Investigator Site - San Antonio

San Antonio, Texas, United States

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Investigator Site - Salt Lake City

Salt Lake City, Utah, United States

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Investigator Site - West Jordan

West Jordan, Utah, United States

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Investigator Site - Midlothian

Midlothian, Virginia, United States

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Investigator Site - Norfolk

Norfolk, Virginia, United States

Site Status

Investigator Site - Kenosha

Kenosha, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 30747908 (View on PubMed)

Related Links

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https://journals.lww.com/pain/Fulltext/2019/06000/SUMMIT_07__a_randomized_trial_of_NKTR_181,_a_new.13.aspx

Related Info

Other Identifiers

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14-181-07

Identifier Type: -

Identifier Source: org_study_id

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