Phase 2
Completed N=213
A Phase 2 Study To Assess The Efficacy, Tolerability, And Safety OF NKTR-181 In Subjects With Chronic OA Knee Pain
Source: ClinicalTrials.gov NCT01619839 ↗Enrolled (actual)
213
Serious AEs
0.7%
Results posted
Aug 2021
Primary outcomePrimary: The Mean Change From Baseline Pain Score to Pain Score at the End of the Double-blind Randomized Treatment Period. — -0.06; -0.01 Change in Pain Score
Summary
NKTR-181 is being developed as an analgesic compound for the treatment of moderate to severe chronic pain - active as a mu agonist, but with inherent molecular properties designed to provide a unique clinical profile, including most notably, reduced CNS side effects and an attenuated attractiveness as a target of abuse.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Mean Change From Baseline Pain Score to Pain Score at the End of the Double-blind Randomized Treatment Period. |
-0.06; -0.01 | — |
| SECONDARY Time to Discontinuation During the Double-blind Randomized Treatment Period for Any Reason |
20.2; 20.2 | — |
Eligibility Criteria
Inclusion Criteria
- Willing and able to give written informed consent;
- Willing and able to understand the study procedures, and comply with all study procedures;
- Females or males, age ≥ 18 years old;
- Body mass index 18-39, inclusive;
- In good general health;
- Clinical diagnosis of OA in one or both knees;
- Have been on a stable regimen of pain medication for the management of OA knee pain;
- Not experiencing adequate pain relief with their current dosing regimen;
- Women of childbearing potential (WCBP) must agree to use highly effective methods of birth control. Male subjects must agree to use contraception.
Exclusion Criteria
- Females who are pregnant or lactating;
- Known history of hypersensitivity, intolerance, or allergy to opioids;
- Diagnosed as having any chronic pain symptom that in the Investigator's opinion would interfere with the assessment of pain and other symptoms of OA;
- Presence of any medical condition that would preclude study participation in the opinion of the investigator;
- Clinically significant abnormalities of vital signs or clinical laboratory results;
- Clinically significant electrocardiographic abnormalities;
- Received systemic corticosteroids within 30 days prior to signing the consent form;
- Subjects who are known or suspected to be currently abusing alcohol or drugs;
- Positive urine drug screen, or alcohol breath test during Screening Period testing;
- Positive serology for the surface antigen of Hepatitis B (HBsAg) or Hepatitis C (anti-HCV) during Screening Period testing;
- Known to be human immunodeficiency virus (HIV) positive;
- Donation of blood or plasma within 30 days prior to signing the consent form;
- Participation in another drug or biologic study within 30 days prior to signing the consent form;
- Any other reason that, in the opinion of the Investigator or Medical Monitor, would render the subject unsuitable for participation in the study.
Data sourced from ClinicalTrials.gov (NCT01619839). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.