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

NCT02362672 | Completed Phase 3 Results

• 1 other identifier: 14-181-07
• Study Type: interventional
• Target: 1,189
• Locations: 1 country
• Sites: 54

Brief 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.

Conditions

Low Back Pain; Chronic Pain

Outcome Measures

Primary Outcomes (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).

  12 Weeks of randomized double blinded period

Secondary Outcomes (5)

• Responder Analysis Based on Percent Reduction in Pain Intensity

  Screening Baseline through Week 12

• Patient Global Impression of Change (PGIC): Number of Responders

  Screening Baseline through Week 12

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

  Screening Baseline through Week 12

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

  Screening Baseline through Week 12

• Change in Roland Morris Disability Questionnaire (RMDQ)

  Screening Baseline through Week 12

Study Arms (2)

NKTR-181

EXPERIMENTAL

NKTR-181 twice daily (BID) tablets

Drug: NKTR-181 BID tablets

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo to match NKTR-181 BID tablets

Interventions

NKTR-181 BID tablets DRUG

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

NKTR-181

Placebo to match NKTR-181 BID tablets DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nektar Therapeutics: lead

Study Sites (54)

Investigator Site - Saraland

Saraland, Alabama, 36571, United States

Location

Investigator Site - Phoenix

Phoenix, Arizona, 85023, United States

Location

Investigator Site - Tempe

Tempe, Arizona, 85283, United States

Location

Investigator Site - Little Rock

Little Rock, Arkansas, 72211, United States

Location

Investigator Site - Stamford

Stamford, Connecticut, 06905, United States

Location

Investigator Site - Clearwater

Clearwater, Florida, 33765, United States

Location

Investigator Site - Fort Lauderdale

Fort Lauderdale, Florida, 33312, United States

Location

Investigator Site - Jacksonville

Jacksonville, Florida, 32257, United States

Location

Investigator Site - Orlando

Orlando, Florida, 32806, United States

Location

Investigator Site - Ormond Beach

Ormond Beach, Florida, 32174, United States

Location

Investigator Site - Plantation

Plantation, Florida, 33324, United States

Location

Investigator Site - Tampa

Tampa, Florida, 33603, United States

Location

Investigator Site - West Palm Beach

West Palm Beach, Florida, 33409, United States

Location

Investigator Site - Atlanta

Atlanta, Georgia, 30338, United States

Location

Investigator Site - Blue Ridge

Blue Ridge, Georgia, 30513, United States

Location

Investigator Site - Marietta

Marietta, Georgia, 30060, United States

Location

Investigator Site - Norcross

Norcross, Georgia, 30092, United States

Location

Investigator Site - Gurnee

Gurnee, Illinois, 60031, United States

Location

Investigator Site - West Des Moines

West Des Moines, Iowa, 50265, United States

Location

Investigator Site - Wichita

Wichita, Kansas, 67207, United States

Location

Investigator Site - Louisville

Louisville, Kentucky, 40213, United States

Location

Investigator Site - Bossier

Bossier City, Louisiana, 71111, United States

Location

Investigator Site - New Orleans

New Orleans, Louisiana, 70115, United States

Location

Investigator Site - Shreveport

Shreveport, Louisiana, 71105, United States

Location

Investigator Site - Bay City

Bay City, Michigan, 48706, United States

Location

Investigator Site - Pinconning

Pinconning, Michigan, 48706, United States

Location

Investigator Site - Biloxi

Biloxi, Mississippi, 39531, United States

Location

Investigator Site - Saint Louis 1

St Louis, Missouri, 63141, United States

Location

Investigator Site - Saint Louis 2

St Louis, Missouri, 63141, United States

Location

Investigator Site - Omaha

Omaha, Nebraska, 68134, United States

Location

Investigator Site - Las Vegas 2

Las Vegas, Nevada, 89102, United States

Location

Investigator Site - Las Vegas 1

Las Vegas, Nevada, 89119, United States

Location

Investigator Site - Rochester

Rochester, New York, 14642, United States

Location

Investigator Site - Williamsville

Williamsville, New York, 14221, United States

Location

Investigator Site - Greensboro

Greensboro, North Carolina, 27410, United States

Location

Investigator Site - Winston Salem

Winston-Salem, North Carolina, 27103, United States

Location

Investigator Site - Fargo

Fargo, North Dakota, 58104, United States

Location

Investigator Site - Beavercreek

Beavercreek, Ohio, 45432, United States

Location

Investigator Site - Cincinnati 1

Cincinnati, Ohio, 45219, United States

Location

Investigator Site - Cincinnati 2

Cincinnati, Ohio, 45246, United States

Location

Investigator Site - Columbus

Columbus, Ohio, 43235, United States

Location

Investigator Site - Duncansville

Duncansville, Pennsylvania, 16635, United States

Location

Investigator Site - Jenkintown

Jenkintown, Pennsylvania, 19046, United States

Location

Investigator Site - Rapid City

Rapid City, South Dakota, 57702, United States

Location

Investigator Site - Memphis

Memphis, Tennessee, 38119, United States

Location

Investigator Site - Arlington

Arlington, Texas, 76012, United States

Location

Investigator Site - Austin

Austin, Texas, 78731, United States

Location

Investigator Site - Killeen

Killeen, Texas, 76543, United States

Location

Investigator Site - San Antonio

San Antonio, Texas, 78229, United States

Location

Investigator Site - Salt Lake City

Salt Lake City, Utah, 84124, United States

Location

Investigator Site - West Jordan

West Jordan, Utah, 84088, United States

Location

Investigator Site - Midlothian

Midlothian, Virginia, 23114, United States

Location

Investigator Site - Norfolk

Norfolk, Virginia, 23507, United States

Location

Investigator Site - Kenosha

Kenosha, Wisconsin, 53142, United States

Location

Related Publications (1)

• 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.

  PMID: 30747908 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Low Back Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Medical Affairs
• Organization: Nektar Therapeutics

StudyInquiry@nektar.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2015
• First Posted: February 13, 2015
• Study Start: March 11, 2015
• Primary Completion: December 1, 2016
• Study Completion: February 1, 2017
• Last Updated: September 16, 2020
• Results First Posted: September 16, 2020

Record last verified: 2020-09

Locations

US (54)