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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 Site Alabaster, Alabama  
Research Site Mesa, Arizona  
Research Site Bentonville, Arkansas  
Research Site Anaheim, California  
Research Site Boulder, Colorado  
Research Site Boca Raton, Florida  
Research Site Albany, Georgia  
Research Site Honolulu, Hawaii  
Research Site Arlington Heights, Illinois  
Research Site Bloomington, Indiana  
Research Site Ashland, Kentucky  
Research Site Baton Rouge, Louisiana  
Research Site Baltimore, Maryland  
Research Site Beverly, Massachusetts  
Research Site Battle Kreek, Michigan  
Research Site Hattiesburg, Mississippi  
Research Site Branson, Missouri  
Research Site Billings, Montana  
Research Site Grand Island, Nebraska  
Research Site Las Vegas, Nevada  
Research Site Belleville, New Jersey  
Research Site Albany, New York  
Research Site Asheville, North Carolina  
Research Site Bismarck, North Dakota  
Research Site Akron, Ohio  
Research Site Allentown, Pennsylvania  
Research Site Pawtucket, Rhode Island  
Research Site Charleston, South Carolina  
Research Site Chattanooga, Tennessee  
Research Site Abilene, Texas  
Research Site Abington, Virginia