Assessment of Efficacy and Safety in Relieving Opioid-induced Constipation in Patients With Cancer-related Pain

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01384292
• Date of registration: 28/06/2011
• Primary sponsor: AstraZeneca
• Public title: Assessment of Efficacy and Safety in Relieving Opioid-induced Constipation in Patients With Cancer-related Pain
• Scientific title: 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
• Date of first enrolment: June 2011
• Target sample size: 336
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01384292
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

Australia, Belgium, Bulgaria, Croatia, Czech Republic, Germany, Hungary, Poland, Puerto Rico, Romania, Slovakia, South Africa, Spain, United Kingdom, United States

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Opioid-Induced Constipation

Intervention(s)

Drug: NKTR-118

Drug: Placebo

Primary Outcome(s)

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. [Time Frame: Will be collected daily through the 4-week treatment period.]

Secondary Outcome(s)

Part A and B: Change from baseline in Patient Assessment of Constipation Symptoms (PAC-SYM) and Patient Assessment of Constipation Quality of Life (PAC-QOL) total score and each domain score for Weeks 2 and 4. [Time Frame: Part A: Will be evaluated at Visits 3, 5 and 6. Part B: will be evaluated at Visits 4 and 6.]

Part A and Part B: Change from baseline in RFBMs/week [Time Frame: Will be collected daily through the 4-week treatment period as well as the 12 week extension]

Part A and Part B: mean number of days per week with at least 1 RFBM. [Time Frame: Will be collected daily through the 4-week treatment period as well as athe 12 week extension]

Part A: Change from baseline in stool consistency (BSS) during the 4-week placebo-controlled treatment period. [Time Frame: Will be collected daily through the 4-week treatment period .part A only.]

Part A: Change from baseline in the degree of straining associated with RFBMs during the 4-week placebo-controlled treatment period. [Time Frame: Will be collected daily through the 4-week treatment period part A only.]

Part A: Percentage of days with complete evacuation during the 4-week placebo-controlled treatment period. [Time Frame: Will be collected daily through the 4-week treatment period part A only.]

Part A: Time (in hours) to first post-dose RFBM [Time Frame: Will be collected daily through the 4-week treatment period part A only.]

Secondary ID(s)

2011-001985-16

D3820C00006

Source(s) of Monetary Support

Please refer to primary and secondary sponsors