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Trial record 2 of 3 for:    NKTR-181

Efficacy and Safety Study of NKTR-181 in Opioid-Naive Subjects With Low Back Pain (SUMMIT-07)

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ClinicalTrials.gov Identifier: NCT02362672
Recruitment Status : Completed
First Posted : February 13, 2015
Last Update Posted : October 17, 2017
Sponsor:
Information provided by (Responsible Party):
Nektar Therapeutics

Brief Summary:
The purpose of this study is to determine whether a new opioid molecule, NKTR-181, is effective for the relief of moderate to severe chronic low back pain as compared to a placebo.

Condition or disease Intervention/treatment Phase
Low Back Pain Chronic Pain Drug: NKTR-181 BID tablets Drug: Placebo to match NKTR-181 BID tablets Phase 3

Detailed Description:
This is an enriched enrollment, randomized withdrawal study with an open label, dose-titration period followed by a randomized, double-blind, placebo-control treatment of twelve weeks. During the double-blind treatment period, this study will evaluate the analgesic effect of NKTR-181 versus placebo in patients with moderate to severe chronic low back pain.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 610 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of NKTR-181 in Opioid-Naive Subjects With Moderate to Severe Chronic Low Back Pain
Study Start Date : February 2015
Primary Completion Date : December 2016
Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Arm Intervention/treatment
Experimental: NKTR-181
NKTR-181 twice daily (BID) tablets
Drug: NKTR-181 BID tablets
NKTR-181 tablets 100-400 mg twice daily (BID)
Placebo Comparator: Placebo
Placebo to match NKTR-181 twice daily (BID) tablets
Drug: Placebo to match NKTR-181 BID tablets
Placebo to match NKTR-181 tablets 100-400 mg twice daily (BID)



Primary Outcome Measures :
  1. Change in Pain [ Time Frame: 12 Weeks ]
    Change in Pain Scores from baseline to Week 12 of treatment period



Information from the National Library of Medicine

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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 non-neuropathic low back pain for at least six months
  • Not experiencing adequate pain relief or have failed previous treatment with non-opioid analgesics
  • Opioid analgesia is necessary
  • Currently taking no more than 10 mg morphine sulfate equivalents per day of short acting opioids for 14 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:

  • Taking extended release or long-acting opioids within 6 months
  • History of hypersensitivity, intolerance, or allergy to opioids
  • Compression of spinal nerve root; spinal fracture, tumor, or abscess
  • Surgical procedures on the low back in the last 12 months or facet nerve root block or radiofrequency ablation in the last 3 months
  • Untreated moderate to severe sleep apnea

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): NCT02362672


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Sponsors and Collaborators
Nektar Therapeutics

Additional Information:
Responsible Party: Nektar Therapeutics
ClinicalTrials.gov Identifier: NCT02362672     History of Changes
Other Study ID Numbers: 14-181-07
First Posted: February 13, 2015    Key Record Dates
Last Update Posted: October 17, 2017
Last Verified: October 2017

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