Last updated on July 2018

Chronic Low Back Pain ( Moderate to Severe )


Brief description of study

Chronic Low Back Pain ( Moderate to Severe )

Detailed Study Description

SUMMIT Phase 3 Program
The SUMMIT Phase 3 program for NKTR-181 includes two enriched-enrollment, randomized withdrawal (EERW) efficacy and safety studies and a 52-week long-term safety study (SUMMIT-LTS). Enrollment has begun in the first Phase 3 efficacy study (SUMMIT-07) which will evaluate NKTR-181 versus placebo in opioid-naïve patients with chronic low back pain.

NKTR-181 is a new chemical entity (NCE) that was created using Nektar's proprietary small molecule polymer conjugate technology. NKTR-181 has several potential differentiating properties that are inherent to the structure of the molecule, including a slow rate of entry into the CNS as measured by pupillometry (contraction of the pupils) and a plasma pharmacokinetic profile that supports twice-daily oral dosing. NKTR-181 is not a reformulation of a marketed opioid, which is a commonly-used method to attempt to prevent the manipulation of existing long-acting opioid drugs into more abusable forms. NKTR-181 has been granted has been granted Fast Track designation for the treatment of moderate to severe chronic pain by the U.S. Food and Drug Administration.

http://www.nektar.com/product_pipeline/cns_pain_nktr-181.html

Clinical Study Identifier: TX140792

Contact Investigators or Research Sites near you

Start Over
Sorry. There are no research Sites conducting this study in the radius provided. ( View all Sites )

Recruitment Status: Closed


Brief Description Eligibility Contact Research Team


Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.