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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02367820
First Posted: February 20, 2015
Last Update Posted: September 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nektar Therapeutics
  Purpose
The purpose of this 52-week open label study is to determine the safety of a new opioid molecule, NKTR-181, in patients with moderate to severe chronic low back pain or chronic non-cancer pain.

Condition Intervention Phase
Low Back Pain Chronic Pain Drug: NKTR-181 BID tablets Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Nektar Therapeutics:

Primary Outcome Measures:
  • To evaluate the long-term safety and tolerability of NKTR-181 in subjects with moderate to severe chronic low back pain or chronic noncancer pain. [ Time Frame: 52 Weeks ]

Secondary Outcome Measures:
  • To evaluate the efficacy of NKTR-181 as measured by the modified Brief Pain Inventory-Short Form (mBPI-SF). [ Time Frame: 52 Weeks ]

Enrollment: 638
Study Start Date: March 2015
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NKTR-181
NKTR-181 twice daily (BID) tablets
Drug: NKTR-181 BID tablets
NKTR-181 tablets 100-600 mg twice daily (BID)

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 or SUMMIT-12 studies.

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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02367820


  Show 56 Study Locations
Sponsors and Collaborators
Nektar Therapeutics
  More Information

Responsible Party: Nektar Therapeutics
ClinicalTrials.gov Identifier: NCT02367820     History of Changes
Other Study ID Numbers: 14-181-08
First Submitted: February 9, 2015
First Posted: February 20, 2015
Last Update Posted: September 19, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms