Long-Term Safety and Tolerability Study of NKTR-181 in Subjects With Chronic Low Back Pain or Chronic Non-Cancer Pain

Phase 3

Completed

• Conditions: Low Back Pain; Chronic Pain
• Interventions: Drug: NKTR-181 BID tablets

• Registration Number: NCT02367820
• Lead Sponsor: Nektar Therapeutics

Brief Summary

The purpose of this 52-week open label study is to determine the long-term safety of a new opioid molecule, NKTR-181, in patients with moderate to severe chronic low back pain or chronic non-cancer pain.

Detailed Description

This is an open-label safety and tolerability study in which approximately 600 subjects will receive NKTR-181 for up to 52 weeks. Subjects may include newly enrolled subjects and subjects who have recently completed SUMMIT-07 study.

This study will also investigate the pharmacokinetics of NKTR-181 in patients with chronic low back pain or chronic non-cancer pain.

Study Timeline

• Study First Submitted: 2015-02-09
• Study First Submitted QC: 2015-02-13
• Study First Posted: 2015-02-20
• Study Start: 2015-04-14
• Primary Completion: 2017-12
• Study Completion: 2018-01
• Disposition First Submitted: 2018-03-02
• Disposition First Submitted QC: 2018-03-02
• Disposition First Posted: 2018-03-06
• Results First Submitted: 2020-06-22
• Results First Submitted QC: 2020-09-14
• Results First Posted: 2020-10-08
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-15
• Last Update Posted: 2021-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 638

Inclusion Criteria

• Male or non-pregnant, non-nursing female aged 18 to 75 years old
• Clinical diagnosis of moderate to severe, chronic low back or non-cancer pain for at least three months
• Not experiencing adequate pain relief or have failed previous treatment with non-opioid analgesics
• Opioid analgesia is necessary
• Currently taking no less than 10 mg but no more than 60 mg of morphine sulfate equivalents (MSE) per day of opioid analgesics for at least 7 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

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Exclusion Criteria

• History of hypersensitivity, intolerance, or allergy to opioids
• Surgical procedures in the last 4 weeks or plans to undergo surgical procedures during the study period
• Untreated moderate to severe sleep apnea
• Chronic migraines as the primary pain condition
• Cancer related pain

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NKTR-181	NKTR-181 BID tablets	NKTR-181 twice daily (BID) tablets

Primary Outcome Measures

Name	Time	Method
Number of Participants Reporting Adverse Events	Screening baseline through end of study, an average of 57 weeks	Count of subjects reporting treatment emergent adverse events

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52	Baseline, monthly change from baseline till the end of study	A self-reported scale measuring severity of pain on function. The mean of the 4 intensity items (3-6) is calculated and used as a measure of pain severity. If there were missing items when the pain severity score was calculated, the mean of the completed items in one dimension (dimensions include pain severity and pain interference) were imputed to substitute the missing item, provided that more than 50% of the items in one dimension were completed (Halling, 1999). The range of pain intensity and interference for each question is from 0 to 10. The range of possible scores is from 0 to 70. Higher score indicates relatively worse pain severity and greater interference that pain causes in day to day activities.
Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52	Baseline, monthly change from baseline till the end of study	A self-reported scale measuring interference of pain on function. The mean of the 7 interference items was calculated and used as a measure of Pain interference. If there were missing items when the pain interference score was calculated, the mean of the completed items in one dimension (dimensions include pain severity and pain interference) were imputed to substitute the missing item, provided that more than 50% of the items in one dimension were completed (Halling, 1999). The range of pain interference is from 0 to 10. Higher score indicates relatively worse pain problem.

Trial Locations

Locations (56)

Investigator Site - Stamford; 🇺🇸 Stamford, Connecticut, United States

Investigator Site - Tempe; 🇺🇸 Tempe, Arizona, United States

Investigator Site - Plantation; 🇺🇸 Plantation, Florida, United States

Investigator Site - Fort Lauderdale; 🇺🇸 Fort Lauderdale, Florida, United States

Investigator Site - Greensboro; 🇺🇸 Greensboro, North Carolina, United States

Investigator Site - Arlington; 🇺🇸 Arlington, Texas, United States

Investigator Site - West Jordan; 🇺🇸 West Jordan, Utah, United States

Investigator Site - Kenosha; 🇺🇸 Kenosha, Wisconsin, United States

Investigator Site - Las Vegas 2; 🇺🇸 Las Vegas, Nevada, United States

Investigator Site - Cincinnati 1; 🇺🇸 Cincinnati, Ohio, United States

Investigator Site - Cincinnati 2; 🇺🇸 Cincinnati, Ohio, United States

Investigator Site - San Antonio; 🇺🇸 San Antonio, Texas, United States

Investigator Site - Phoenix; 🇺🇸 Phoenix, Arizona, United States

Investigator Site - Winston Salem; 🇺🇸 Winston-Salem, North Carolina, United States

Investigator Site - Killeen; 🇺🇸 Killeen, Texas, United States

Investigator Site - Tampa; 🇺🇸 Tampa, Florida, United States

Investigator Site - Clearwater; 🇺🇸 Clearwater, Florida, United States

Investigator Site - Fort Myers; 🇺🇸 Fort Myers, Florida, United States

Investigator Site - Columbus; 🇺🇸 Columbus, Ohio, United States

Investigator Site - Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Investigator Site - Saraland; 🇺🇸 Saraland, Alabama, United States

Investigator Site - Little Rock; 🇺🇸 Little Rock, Arkansas, United States

Investigator Site - West Palm Beach; 🇺🇸 West Palm Beach, Florida, United States

Investigator Site - Gurnee; 🇺🇸 Gurnee, Illinois, United States

Investigator Site - Wichita; 🇺🇸 Wichita, Kansas, United States

Investigator Site - Atlanta; 🇺🇸 Atlanta, Georgia, United States

Investigator Site - Marietta; 🇺🇸 Marietta, Georgia, United States

Investigator Site - Shreveport; 🇺🇸 Shreveport, Louisiana, United States

Investigator Site - West Des Moines; 🇺🇸 West Des Moines, Iowa, United States

Investigator Site - Bay City; 🇺🇸 Bay City, Michigan, United States

Investigator Site - Louisville; 🇺🇸 Louisville, Kentucky, United States

Investigator Site - New Orleans; 🇺🇸 New Orleans, Louisiana, United States

Investigator Site - Las Vegas 1; 🇺🇸 Las Vegas, Nevada, United States

Investigator Site - Omaha; 🇺🇸 Omaha, Nebraska, United States

Investigator Site - Williamsville; 🇺🇸 Williamsville, New York, United States

Investigator Site - Norcross; 🇺🇸 Norcross, Georgia, United States

Investigator Site - Ormond Beach; 🇺🇸 Ormond Beach, Florida, United States

Investigator Site - Blue Ridge; 🇺🇸 Blue Ridge, Georgia, United States

Investigator Site - Pinconning; 🇺🇸 Pinconning, Michigan, United States

Investigator Site - Bossier; 🇺🇸 Bossier City, Louisiana, United States

Investigator Site - Saint Louis 1; 🇺🇸 Saint Louis, Missouri, United States

Investigator Site - Saint Louis 2; 🇺🇸 Saint Louis, Missouri, United States

Investigator Site - Fargo; 🇺🇸 Fargo, North Dakota, United States

Investigator Site - Jenkintown; 🇺🇸 Jenkintown, Pennsylvania, United States

Investigator Site - Dakota Dunes; 🇺🇸 Dakota Dunes, South Dakota, United States

Investigator Site - Rapid City; 🇺🇸 Rapid City, South Dakota, United States

Investigator Site - Austin; 🇺🇸 Austin, Texas, United States

Investigator Site - Salt Lake City; 🇺🇸 Salt Lake City, Utah, United States

Investigator Site - Midlothian; 🇺🇸 Midlothian, Virginia, United States

Investigator Site - Biloxi; 🇺🇸 Biloxi, Mississippi, United States

Investigator Site - Orlando; 🇺🇸 Orlando, Florida, United States

Investigator Site - Beavercreek; 🇺🇸 Beavercreek, Ohio, United States

Investigator Site - Rochester; 🇺🇸 Rochester, New York, United States

Investigator Site - Memphis; 🇺🇸 Memphis, Tennessee, United States

Investigator Site - Duncansville; 🇺🇸 Duncansville, Pennsylvania, United States

Investigator Site - Norfolk; 🇺🇸 Norfolk, Virginia, United States