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

Nektar Therapeutics

Status and phase: Completed; Phase 3

Conditions: Chronic Pain; Low Back Pain

Treatments: Drug: Placebo to match NKTR-181 BID tablets; Drug: NKTR-181 BID tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT02362672

14-181-07

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,189 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,189 participants in 2 patient groups, including a placebo group

NKTR-181

Experimental group

Description:

NKTR-181 twice daily (BID) tablets

Treatment:

Drug: NKTR-181 BID tablets

Placebo

Placebo Comparator group

Description:

Placebo to match NKTR-181 twice daily (BID) tablets

Treatment:

Drug: Placebo to match NKTR-181 BID tablets