Clinical trial NCT02362672: Efficacy and Safety Study of NKTR-181 in Opioid-Naive Subjects With Low Back Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Low Back Pain
Chronic Pain
Lead sponsor: Nektar Therapeutics
Sponsor class: INDUSTRY
First posted: 2015-02-13
Enrollment: 1189
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
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)
timeFrame: 12 Weeks of randomized double blinded period
Secondary outcomes:
measure: Responder Analysis Based on Percent Reduction in Pain Intensity
timeFrame: Screening Baseline through Week 12
measure: Patient Global Impression of Change (PGIC): Number of Responders
timeFrame: Screening Baseline through Week 12
measure: Change in Sleep Quality in the Medical Outcome Study Sleep Scale - Revised (MOS Sleep-R)
timeFrame: Screening Baseline through Week 12
measure: Change in Sleep Quantity Measure in Hours in the Medical Outcome Study Sleep Scale - Revised (MOS Sleep-R)
timeFrame: Screening Baseline through Week 12
measure: Change in Roland Morris Disability Questionnaire (RMDQ)
timeFrame: Screening Baseline through Week 12
Other outcomes:
Locations:
city: Saraland
country: United States
facility: Investigator Site - Saraland
state: Alabama
city: Phoenix
country: United States
facility: Investigator Site - Phoenix
state: Arizona
city: Tempe
country: United States
facility: Investigator Site - Tempe
state: Arizona
city: Little Rock
country: United States
facility: Investigator Site - Little Rock
state: Arkansas
city: Stamford
country: United States
facility: Investigator Site - Stamford
state: Connecticut
city: Clearwater
country: United States
facility: Investigator Site - Clearwater
state: Florida
city: Fort Lauderdale
country: United States
facility: Investigator Site - Fort Lauderdale
state: Florida
city: Jacksonville
country: United States
facility: Investigator Site - Jacksonville
state: Florida
city: Orlando
country: United States
facility: Investigator Site - Orlando
state: Florida
city: Ormond Beach
country: United States
facility: Investigator Site - Ormond Beach
state: Florida
city: Plantation
country: United States
facility: Investigator Site - Plantation
state: Florida
city: Tampa
country: United States
facility: Investigator Site - Tampa
state: Florida
city: West Palm Beach
country: United States
facility: Investigator Site - West Palm Beach
state: Florida
city: Atlanta
country: United States
facility: Investigator Site - Atlanta
state: Georgia
city: Blue Ridge
country: United States
facility: Investigator Site - Blue Ridge
state: Georgia
city: Marietta
country: United States
facility: Investigator Site - Marietta
state: Georgia
city: Norcross
country: United States
facility: Investigator Site - Norcross
state: Georgia
city: Gurnee
country: United States
facility: Investigator Site - Gurnee
state: Illinois
city: West Des Moines
country: United States
facility: Investigator Site - West Des Moines
state: Iowa
city: Wichita
country: United States
facility: Investigator Site - Wichita
state: Kansas
city: Louisville
country: United States
facility: Investigator Site - Louisville
state: Kentucky
city: Bossier City
country: United States
facility: Investigator Site - Bossier
state: Louisiana
city: New Orleans
country: United States
facility: Investigator Site - New Orleans
state: Louisiana
city: Shreveport
country: United States
facility: Investigator Site - Shreveport
state: Louisiana
city: Bay City
country: United States
facility: Investigator Site - Bay City
state: Michigan
city: Pinconning
country: United States
facility: Investigator Site - Pinconning
state: Michigan
city: Biloxi
country: United States
facility: Investigator Site - Biloxi
state: Mississippi
city: Saint Louis
country: United States
facility: Investigator Site - Saint Louis 1
state: Missouri
city: Saint Louis
country: United States
facility: Investigator Site - Saint Louis 2
state: Missouri
city: Omaha
country: United States
facility: Investigator Site - Omaha
state: Nebraska
city: Las Vegas
country: United States
facility: Investigator Site - Las Vegas 2
state: Nevada
city: Las Vegas
country: United States
facility: Investigator Site - Las Vegas 1
state: Nevada
city: Rochester
country: United States
facility: Investigator Site - Rochester
state: New York
city: Williamsville
country: United States
facility: Investigator Site - Williamsville
state: New York
city: Greensboro
country: United States
facility: Investigator Site - Greensboro
state: North Carolina
city: Winston-Salem
country: United States
facility: Investigator Site - Winston Salem
state: North Carolina
city: Fargo
country: United States
facility: Investigator Site - Fargo
state: North Dakota
city: Beavercreek
country: United States
facility: Investigator Site - Beavercreek
state: Ohio
city: Cincinnati
country: United States
facility: Investigator Site - Cincinnati 1
state: Ohio
city: Cincinnati
country: United States
facility: Investigator Site - Cincinnati 2
state: Ohio
city: Columbus
country: United States
facility: Investigator Site - Columbus
state: Ohio
city: Duncansville
country: United States
facility: Investigator Site - Duncansville
state: Pennsylvania
city: Jenkintown
country: United States
facility: Investigator Site - Jenkintown
state: Pennsylvania
city: Rapid City
country: United States
facility: Investigator Site - Rapid City
state: South Dakota
city: Memphis
country: United States
facility: Investigator Site - Memphis
state: Tennessee
city: Arlington
country: United States
facility: Investigator Site - Arlington
state: Texas
city: Austin
country: United States
facility: Investigator Site - Austin
state: Texas
city: Killeen
country: United States
facility: Investigator Site - Killeen
state: Texas
city: San Antonio
country: United States
facility: Investigator Site - San Antonio
state: Texas
city: Salt Lake City
country: United States
facility: Investigator Site - Salt Lake City
state: Utah
city: West Jordan
country: United States
facility: Investigator Site - West Jordan
state: Utah
city: Midlothian
country: United States
facility: Investigator Site - Midlothian
state: Virginia
city: Norfolk
country: United States
facility: Investigator Site - Norfolk
state: Virginia
city: Kenosha
country: United States
facility: Investigator Site - Kenosha
state: Wisconsin
Study officials:
References:
citation: 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.