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A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NKTR-118 in Relieving Opioid-Induced Constipation (OIC) in Patients With Cancer-Related Pain


Phase 3
18 Years
N/A
Not Enrolling
Both
Opioid-Induced Constipation

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Trial Information

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NKTR-118 in Relieving Opioid-Induced Constipation (OIC) in Patients With Cancer-Related Pain


Inclusion Criteria:



- Provision of written informed consent prior to any study-specific procedures.

- Men and women aged 18 or older.

- Histologically or cytologically confirmed neoplasm causing pain and requiring
management with opioids.

- Self-reported active symptoms of OIC at screening (<3 RFBMs/week and experiencing >1
reported symptom of hard/lumpy stools, straining, or sensation of incomplete
evacuation/anorectal obstruction in at least 25% of BMs over the previous 4 weeks);
and Documented confirmed OIC (<3 RFBMs/week on average aver the 2-week OIC
confirmation period.

- Receiving a stable maintenance opioid regimen consisting of a total daily dose of >30
mg of oral morphine, or equianalgesic amount(s) of 1 or more opioid therapies for a
minimum of 4 weeks prior to screening for cancer-related pain with no anticipated
change in opioid dose requirement over the proposed study period as a result of
disease progression.

Exclusion Criteria:

- Patients receiving Opioid regimen for treatment of pain other than related to cancer.

- Any condition that may have affected the permeability of the blood-brain barrier, eg,
known brain metastases, meningeal metastases, brain injury, multiple sclerosis,
recent brain injury, uncontrolled epilepsy.

- Patients with cancer-related pain due to ovarian cancer, leukaemia, or lymphoma are
excluded. Patients with multiple myeloma will be allowed.

- Patients requiring radiation therapy between the diaphragm and pelvis 4 weeks prior
to Visit 1 (screening) and/or during Part A of the study are excluded. Any patients
with suspected clinically relevant radiation-induced injury of small or large
intestine are excluded.

- Pregnancy or lactation.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Response to study drug, defined as having at least 3 Rescue-free bowel movements (RFBMs) per week during the 4-week treatment period, with at least 1 RFBM per week increase over baseline for at least 3 out of 4 weeks.

Outcome Description:

Response (responder/non-responder) to study drug, where a responder is defined as having at least 3 Rescue-free bowel movements (RFBMs) per week during the 4-week treatment period, with at least 1 RFBM per week increase over baseline for at least 3 out of 4 weeks.

Outcome Time Frame:

Will be collected daily through the 4-week treatment period.

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

D3820C00006

NCT ID:

NCT01384292

Start Date:

June 2011

Completion Date:

September 2012

Related Keywords:

  • Opioid-Induced Constipation
  • Cancer-Related Pain
  • Opioid-Induced Constipation
  • OIC
  • Constipation

Name

Location

Research SiteAlabaster, Alabama  
Research SiteMesa, Arizona  
Research SiteBentonville, Arkansas  
Research SiteAnaheim, California  
Research SiteBoulder, Colorado  
Research SiteBoca Raton, Florida  
Research SiteAlbany, Georgia  
Research SiteHonolulu, Hawaii  
Research SiteArlington Heights, Illinois  
Research SiteBloomington, Indiana  
Research SiteAshland, Kentucky  
Research SiteBaton Rouge, Louisiana  
Research SiteBaltimore, Maryland  
Research SiteBeverly, Massachusetts  
Research SiteBattle Kreek, Michigan  
Research SiteHattiesburg, Mississippi  
Research SiteBranson, Missouri  
Research SiteBillings, Montana  
Research SiteGrand Island, Nebraska  
Research SiteLas Vegas, Nevada  
Research SiteBelleville, New Jersey  
Research SiteAlbany, New York  
Research SiteAsheville, North Carolina  
Research SiteBismarck, North Dakota  
Research SiteAkron, Ohio  
Research SiteAllentown, Pennsylvania  
Research SitePawtucket, Rhode Island  
Research SiteCharleston, South Carolina  
Research SiteChattanooga, Tennessee  
Research SiteAbilene, Texas  
Research SiteAbington, Virginia