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NCT Number: NCT01395524

A 12-week Extension of the Phase III Study (D3820C00004) to Assess the Effect and Safety of NKTR-118 in Patients With Non-cancer-related Pain and Opioid-induced Constipation

The purpose of this study is to evaluate the effect and safety of NKTR-118 treatment of opioid-induced constipation in patients with non-cancer-related pain over a 6-month period.

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Key information

Conditions

Opioid-induced Constipation (OIC) Chemically-Induced Disorders Constipation Mental Disorders Narcotic-Related Disorders Opioid-Induced Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Substance-Related Disorders

Age range

18 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Broadmeadow, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must have completed the 12-week study D3820C00004 through Visit 8.
  • Provision of written informed consent prior to any study-specific procedures.
  • Men and women who were between the ages of >18 and <85 years at the time of the screening visit for study D3820C00004.
  • Continuing to receive a stable maintenance opioid regimen consisting of a total daily dose of 30 mg to 1000 mg of oral morphine, or equianalgesic amount(s) of 1 or more other opioid therapies.
  • Willingness to continue abstinence from all laxatives and other bowel regimens including prune juice and herbal products throughout this additional 12-week treatment period, and to use only bisacodyl as rescue medication if a bowel movement (BM) has not occurred within at least 72 hours of the last recorded BM.

Exclusion criteria

  • Patients receiving opioid regimen for treatment of pain related to cancer.
  • History of cancer within 5 years from the screening visit of study D3820C00004 with the exception of basal cell cancer and squamous cell skin cancer.
  • Medical conditions and treatments associated with diarrhea, intermittent loose stools, or constipation.
  • Other issues related to the gastrointestinal tract that could impose risk to the patient.
  • Pregnancy or lactation.

Treatment and study plan

NKTR-118

Drug

12.5 mg oral tablet once daily

Placebo

Drug

Oral tablet intake once daily

Primary outcomes

  1. Incidence of Patients Experiencing at Least One Adverse Event (AE)

    Time frame: Baseline (Week 0) to end of the follow-up period (Week 14)

    The incidence of patients experiencing at least one AE during the randomized treatment and follow-up periods was calculated.

  2. Incidence of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP)

    Time frame: Baseline (Week 0) to end of the follow-up period (Week 14)

    The incidence of patients experiencing AEs that resulted in discontinuation of IP during the randomized treatment or follow-up periods was calculated.

  3. Incidence of Patients Experiencing Severe Adverse Events (SAEs)

    Time frame: Baseline (Week 0) to end of the follow-up period (Week 14)

    The incidence of patients experiencing SAEs during the randomized treatment and follow-up periods was calculated.

Secondary outcomes

  1. Change From Baseline in Patient Assessment of Constipation Symptoms Questionnaire (PAC-SYM)

    Time frame: Baseline (prior to treatment) to last on-treatment assessment (up to Week 12)

    The PAC-SYM questionnaire is a 12-item questionnaire that evaluates the severity of symptoms of constipation in 3 domains (stool, rectal, and abdominal symptoms) on a 5-point Likert scale ranging from 0 (absent) to 4 (very severe) in the 2 weeks (14 days) prior to assessment. Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items (ie, symptoms). The range of the domain or total score is 0 (response is 'absent' for each item) to 4 (response is 'very severe' for each item). A negative change from baseline indicates improvement.

  2. Change From Baseline in Patient Assessment of Constipation Quality of Life (PAC-QOL)

    Time frame: Baseline (prior to treatment) to last on-treatment assessment (up to Week 12)

    The PAC-QOL scale is a 28-item self-report instrument designed to evaluate the burden of constipation on patients' everyday functioning and well-being in the 2 weeks (14 days) prior to assessment. Each item is rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely). The instrument can be used to generate an overall score, but is also reported to assess 4 specific constipation-related domains including: 1) Worries and concerns (11 items), 2) Physical discomfort (4 items), 3) Psychosocial discomfort (8 items), and 4) Satisfaction (5 items). Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items. The range of the domain or total score is 0 (response is 'not at all' for each item) to 4 (response is 'extremely' for each item). A negative change from baseline indicates improvement.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled 12-Week Extension Study to Assess the Safety and Tolerability of NKTR-118 in Patients With Non-Cancer-Related Pain and Opioid-Induced Constipation (OIC)

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 15, 2011
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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