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

Nektar Therapeutics638 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

638

Conditions

Low Back Pain Chronic Pain

Interventions

NKTR-181 BID tabletsDRUG

NKTR-181 tablets 100-600 mg twice daily (BID)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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 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

Locations (56)

Outcomes

Primary Outcomes

Number of Participants Reporting Adverse Events

Count of subjects reporting treatment emergent adverse events

Time frame: Screening baseline through end of study, an average of 57 weeks

Secondary Outcomes

Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52

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.

Time frame: Baseline, monthly change from baseline till the end of study

Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52

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.

Time frame: Baseline, monthly change from baseline till the end of study

Data from ClinicalTrials.gov

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Investigator Site - Saraland

Saraland, Alabama, United States

Investigator Site - Phoenix

Phoenix, Arizona, United States

Investigator Site - Tempe

Tempe, Arizona, United States

Investigator Site - Little Rock

Little Rock, Arkansas, United States

Investigator Site - Stamford

Stamford, Connecticut, United States

Investigator Site - Clearwater

Clearwater, Florida, United States

Investigator Site - Fort Lauderdale

Fort Lauderdale, Florida, United States

Investigator Site - Fort Myers

Fort Myers, Florida, United States

Investigator Site - Jacksonville

Jacksonville, Florida, United States

Investigator Site - Orlando

Orlando, Florida, United States

...and 46 more locations