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

Nektar Therapeutics

Status and phase: Completed; Phase 3

Conditions: Chronic Pain; Low Back Pain

Treatments: Drug: NKTR-181 BID tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT02367820

14-181-08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 638 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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638 participants in 1 patient group

NKTR-181

Experimental group

Description:

NKTR-181 twice daily (BID) tablets

Treatment:

Drug: NKTR-181 BID tablets