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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01384292
First received: June 28, 2011
Last updated: September 28, 2012
Last verified: September 2012

June 28, 2011
September 28, 2012
June 2011
September 2012   (final data collection date for primary 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. [ Time Frame: Will be collected daily through the 4-week treatment period. ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01384292 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Regularity during the 4-week treatment period, where regularity is measured as the mean number of days per week with at least 1 RFBM. [ Time Frame: Will be collected daily through the 4-week treatment period. ] [ Designated as safety issue: No ]
  • Time (in hours) to first post-dose RFBM. [ Time Frame: Will be collected daily through the 4-week treatment period. ] [ Designated as safety issue: No ]
  • Change from baseline in the degree of straining associated with RFBMs during the 4-week treatment period. [ Time Frame: Will be collected daily through the 4-week treatment period. ] [ Designated as safety issue: No ]
  • Change from baseline in stool consistency (BSS) during the 4-week treatment period. [ Time Frame: Will be collected daily through the 4-week treatment period. ] [ Designated as safety issue: No ]
  • Percentage of days with complete evacuation during the 4-week treatment period. [ Time Frame: Will be collected daily through the 4-week treatment period. ] [ Designated as safety issue: No ]
  • 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: Will be evaluated at Visits 3, 5 and 6. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Assessment of Efficacy and Safety in Relieving Opioid-induced Constipation in Patients With Cancer-related Pain
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

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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Opioid-Induced Constipation
  • Drug: NKTR-118
    12.5 mg oral tablet once daily
  • Drug: NKTR-118
    25 mg oral tablet once daily
  • Drug: Placebo
    Oral treatment
  • Experimental: 1 (part A and B)
    Oral treatment
    Intervention: Drug: NKTR-118
  • Experimental: 2 (part A and B)
    Oral treatment
    Intervention: Drug: NKTR-118
  • Placebo Comparator: 3 (part A only)
    Oral treatment
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
336
September 2012
September 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   Bulgaria,   Croatia,   Czech Republic,   Germany,   Poland,   Puerto Rico,   Romania,   Slovakia,   South Africa,   Spain,   United Kingdom
 
NCT01384292
D3820C00006, 2011-001985-16
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Not Provided
AstraZeneca
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP