Assessment of Efficacy and Safety in Relieving Opioid-induced Constipation in Patients With Cance… (NCT01384292) | Clinical Trial Compass
TerminatedPhase 3
Assessment of Efficacy and Safety in Relieving Opioid-induced Constipation in Patients With Cancer-related Pain
Stopped: The study was stopped early due to recruitment challenges
United States14 participantsStarted 2011-06
Plain-language summary
The purpose of this study is to compare the effect of NKTR-118 with placebo in the treatment of opioid-induced constipation (OIC) in patients with cancer-related pain, including those patients that have inadequate response to laxative therapy (LIR).
The study consists of 2 parts; A initial 4-week treatment period (part A) and then a 12 week extension with active treatment (part B).
Who can participate
Age range18 Years
SexALL
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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 Vi…