Assessment of Long-term Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation - Full Text View

Purpose

The purpose of this study is to evaluate the long-term safety and tolerability of NKTR-118 treatment of opioid-induced constipation (OIC) in patients with non-cancer-related pain.

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-Label 52-week Study to Assess the Long-Term Safety of NKTR-118 in Opioid-Induced Constipation (OIC) in Patients With Non-Cancer-Related Pain

Resource links provided by NLM:

MedlinePlus related topics: Constipation

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Incidence of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Screening Visit through Final Visit. ] [ Designated as safety issue: Yes ]
Incidence of adverse events (AEs), treatment-related AEs, serious adverse events (SAEs), AEs leading to discontinuation, and specific safety areas of interest.
Nature of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Screening Visit through Final Visit. ] [ Designated as safety issue: Yes ]
Nature of adverse events (AEs), treatment-related AEs, serious adverse events (SAEs), AEs leading to discontinuation, and specific safety areas of interest.
Intensity of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Screening Visit through Final Visit. ] [ Designated as safety issue: Yes ]
Intensity of adverse events (AEs), treatment-related AEs, serious adverse events (SAEs), AEs leading to discontinuation, and specific safety areas of interest.

Secondary Outcome Measures:

Mean daily opioid dose [ Time Frame: Months 1, 3, 6, 9, and 12 ] [ Designated as safety issue: Yes ]
Mean bisacodyl dose per week [ Time Frame: Months 1, 3, 6, 9, and 12 ] [ Designated as safety issue: Yes ]
Change from baseline in numerical rating scale (NRS) pain score [ Time Frame: Week 1, Week 2, Months 1, 2, 3, 6, 9, and 12 ] [ Designated as safety issue: Yes ]
Change from baseline in composite score in modified Himmelsbach scale for the evaluation of centrally mediated opioid withdrawal [ Time Frame: Week 1, Months 1, 3, 6, 9, and 12 ] [ Designated as safety issue: Yes ]
Observed values and change from baseline in composite score in modified Himmelsbach scale for the evaluation of centrally mediated opioid withdrawal symptoms
Changes in vital signs (physical examination) [ Time Frame: Screening Visit through Final Visit. ] [ Designated as safety issue: Yes ]
Changes in laboratory assessments (ie, chemistry, hematology, and U/A) [ Time Frame: Screening Visit through Final Visit. ] [ Designated as safety issue: Yes ]
Changes in electrocardiograms (ECGs) [ Time Frame: Screening Visit through Final Visit. ] [ Designated as safety issue: Yes ]

Enrollment:	844
Study Start Date:	April 2011
Study Completion Date:	December 2012
Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Oral Treatment	Drug: NKTR-118 25 mg oral tablet once daily
Active Comparator: 2 Oral treatment	Drug: Usual care As prescribed by the investigator

Eligibility

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

Criteria

Inclusion Criteria:

Provision of written informed consent prior to any study-specific procedures.
NEW PATIENTS ONLY: Self-reported active symptoms of OIC at screening (<3 SBMs/week and experiencing >1 reported symptom of hard/lumpy stools, straining, or sensation of incomplete evacuation/anorectal obstruction in at least 25% of the BMs over the previous 4 weeks); and Documented confirmed OIC (<3 SBMs/week on average over the 2-week OIC confirmation period.
PATIENTS ENROLLING FROM OTHER NKTR-118 STUDIES: Receiving a stable maintenance opioid regimen consisting of a total daily dose of 30 mg to 1000 mg or oral morphine, or equianalgesic amount(s) of 1 or more opioid therapies.
FOR PATIENTS RANDOMIZED TO RECEIVE NKTR-118: Willingness to stop all laxatives and other bowel regimens including prune juice and herbal products throughout the 52-week treatment period, and to use only bisacodyl as rescue medication if 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 first study visit 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 a risk to the patient.
Pregnancy or lactation.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01336205

Show 170 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Mark Sostek

AstraZeneca

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01336205 History of Changes
Other Study ID Numbers:	D3820C00008
Study First Received:	April 14, 2011
Last Updated:	January 9, 2013
Health Authority:	United States: Food and Drug Administration

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
Analgesics
Sensory System Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants

ClinicalTrials.gov processed this record on May 21, 2013