NCT02367820

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

A Phase 3 Multicenter, Open-Label, 52-Week Study To Evaluate the Long-Term Safety and Tolerability of NKTR-181 in Subjects With Moderate to Severe Chronic Low Back Pain or Chronic Non-Cancer Pain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 638 (actual)
• Sponsor: Nektar Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Low Back Pain
• Chronic Pain

Interventions

Type	Name	Description
DRUG	NKTR-181 BID tablets	NKTR-181 tablets 100-600 mg twice daily (BID)

Timeline

• Start date: 2015-04-14
• Primary completion: 2017-12-01
• Completion: 2018-01-01
• First posted: 2015-02-20
• Last updated: 2021-06-22
• Results posted: 2020-10-08

Locations

56 sites across 1 country: United States