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

Chronic Pain Clinical Trial

— SUMMIT-07  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02362672
• Other study ID #: 14-181-07
• Status: Completed
• Phase: Phase 3
• Start date: March 11, 2015
• Est. completion date: February 2017

Study information

• Verified date: September 2020
• Source: Nektar Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1189
• Est. completion date: February 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Pain
• Low Back Pain

Intervention

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

Locations

Country	Name	City	State
United States	Investigator Site - Arlington	Arlington	Texas
United States	Investigator Site - Atlanta	Atlanta	Georgia
United States	Investigator Site - Austin	Austin	Texas
United States	Investigator Site - Bay City	Bay City	Michigan
United States	Investigator Site - Beavercreek	Beavercreek	Ohio
United States	Investigator Site - Biloxi	Biloxi	Mississippi
United States	Investigator Site - Blue Ridge	Blue Ridge	Georgia
United States	Investigator Site - Bossier	Bossier City	Louisiana
United States	Investigator Site - Cincinnati 1	Cincinnati	Ohio
United States	Investigator Site - Cincinnati 2	Cincinnati	Ohio
United States	Investigator Site - Clearwater	Clearwater	Florida
United States	Investigator Site - Columbus	Columbus	Ohio
United States	Investigator Site - Duncansville	Duncansville	Pennsylvania
United States	Investigator Site - Fargo	Fargo	North Dakota
United States	Investigator Site - Fort Lauderdale	Fort Lauderdale	Florida
United States	Investigator Site - Greensboro	Greensboro	North Carolina
United States	Investigator Site - Gurnee	Gurnee	Illinois
United States	Investigator Site - Jacksonville	Jacksonville	Florida
United States	Investigator Site - Jenkintown	Jenkintown	Pennsylvania
United States	Investigator Site - Kenosha	Kenosha	Wisconsin
United States	Investigator Site - Killeen	Killeen	Texas
United States	Investigator Site - Las Vegas 1	Las Vegas	Nevada
United States	Investigator Site - Las Vegas 2	Las Vegas	Nevada
United States	Investigator Site - Little Rock	Little Rock	Arkansas
United States	Investigator Site - Louisville	Louisville	Kentucky
United States	Investigator Site - Marietta	Marietta	Georgia
United States	Investigator Site - Memphis	Memphis	Tennessee
United States	Investigator Site - Midlothian	Midlothian	Virginia
United States	Investigator Site - New Orleans	New Orleans	Louisiana
United States	Investigator Site - Norcross	Norcross	Georgia
United States	Investigator Site - Norfolk	Norfolk	Virginia
United States	Investigator Site - Omaha	Omaha	Nebraska
United States	Investigator Site - Orlando	Orlando	Florida
United States	Investigator Site - Ormond Beach	Ormond Beach	Florida
United States	Investigator Site - Phoenix	Phoenix	Arizona
United States	Investigator Site - Pinconning	Pinconning	Michigan
United States	Investigator Site - Plantation	Plantation	Florida
United States	Investigator Site - Rapid City	Rapid City	South Dakota
United States	Investigator Site - Rochester	Rochester	New York
United States	Investigator Site - Saint Louis 1	Saint Louis	Missouri
United States	Investigator Site - Saint Louis 2	Saint Louis	Missouri
United States	Investigator Site - Salt Lake City	Salt Lake City	Utah
United States	Investigator Site - San Antonio	San Antonio	Texas
United States	Investigator Site - Saraland	Saraland	Alabama
United States	Investigator Site - Shreveport	Shreveport	Louisiana
United States	Investigator Site - Stamford	Stamford	Connecticut
United States	Investigator Site - Tampa	Tampa	Florida
United States	Investigator Site - Tempe	Tempe	Arizona
United States	Investigator Site - West Des Moines	West Des Moines	Iowa
United States	Investigator Site - West Jordan	West Jordan	Utah
United States	Investigator Site - West Palm Beach	West Palm Beach	Florida
United States	Investigator Site - Wichita	Wichita	Kansas
United States	Investigator Site - Williamsville	Williamsville	New York
United States	Investigator Site - Winston Salem	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Nektar Therapeutics

Country where clinical trial is conducted

United States, 

References & 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-bac — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Screening Baseline through Week 12
Secondary	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.	Screening Baseline through Week 12
Secondary	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.	Screening Baseline through Week 12
Secondary	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.	Screening Baseline through Week 12
Secondary	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.	Screening Baseline through Week 12

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