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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01395524
First received: June 28, 2011
Last updated: September 28, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Opioid-Induced Constipation (OIC)
Drug: NKTR-118
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Incidence, nature, and intensity of adverse events (AEs), treatment-related AEs, serious adverse events (SAEs), AEs leading to discontinuation, and specific safety areas of interest. Changes in vital signs and physical examination. [ Time Frame: AEs collected throughout the study period, from 1st dose to last visit (14 wks). Vital signs collected and performed throughout the study period (14 wks), at all 5 visits. Physical examinations performed at beginning and end of the study period (14 wks). ] [ Designated as safety issue: Yes ]
  • Change from baseline in mean daily prescribed opioid dose. [ Time Frame: Will be collected throughout the study period (14 weeks) at Visits 1, 2, 3, 4 and 5. ] [ Designated as safety issue: Yes ]
  • Mean bisacodyl dose per week. [ Time Frame: Will be assessed for the following time intervals: between enrollment (Visit 1) to Week 4 (Visit 2) and Week 4 (Visit 2) to Week 12 (Visit 4). ] [ Designated as safety issue: Yes ]
  • Change from baseline in Numeric Rating Scale (NRS) pain score. [ Time Frame: Will be calculated at Weeks 4 (Visit 2), 8 (Visit 3) and 12 (Visit 4). ] [ Designated as safety issue: No ]
  • Observed and change from baseline in composite score of modified Himmelsbach scale. [ Time Frame: Will be collected at Enrollment (Visit 1) and Week 12 (Visit 4). ] [ Designated as safety issue: No ]
  • Changes in laboratory assessments (ie chemistry, hematology and urinalysis ) and electrocardiograms (ECGs). [ Time Frame: Laboratory assessments and ECGs will be collected at Enrollment (Visit 1), Week 12 (Visit 4) and Follow-up (Visit 5). Urinalysis will be performed at Enrollment (Visit 1) and Week 12 (Visit 4). ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline in Patient Assessment of Constipation Symptoms (PAC-SYM) [ Time Frame: Will be collected at Enrollment (Visit 1), Week 4 (Visit )2, Week 12 (Visit 4) and Follow-up (Visit 5). ] [ Designated as safety issue: No ]
  • Change from baseline in Patient Assessment of Constipation Quality of Life (PAC-QOL) [ Time Frame: Will be collected at Enrollment (Visit 1), Week 4 (Visit )2, Week 12 (Visit 4) and Follow-up (Visit 5). ] [ Designated as safety issue: No ]

Enrollment: 633
Study Start Date: July 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NKTR-118 12.5mg Drug: NKTR-118
12.5 mg oral tablet once daily
Experimental: NKTR-118 25mg Drug: NKTR-118
25 mg oral tablet once daily
Placebo Comparator: Placebo Drug: Placebo
Oral tablet intake once daily

  Eligibility

Ages Eligible for Study:   18 Years to 84 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01395524

  Show 116 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Mark Sostek AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01395524     History of Changes
Other Study ID Numbers: D3820C00007
Study First Received: June 28, 2011
Last Updated: September 28, 2012
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Germany: Federal Institute for Drugs and Medical Devices
Slovakia: State Institute for Drug Control

Keywords provided by AstraZeneca:
Non-Cancer-Related Pain
Opioid-Induced Constipation.

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014