Assessment of Efficacy and 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 effect and safety of NKTR-118 treatment of opioid-induced constipation in patients with non-cancer-related pain, including those patients that have inadequate response to laxative therapy (LIR).

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NKTR-118 in Patients With Non-Cancer-Related Pain and Opioid-Induced Constipation (OIC)

Resource links provided by NLM:

MedlinePlus related topics: Constipation

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

The primary efficacy endpoint is response (responder/non-responder) to study drug during Weeks 1 to 12, for at least 9 out of 12 weeks, and at least 3 out of the last 4 weeks. [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: No ]
Responder is defined as having at least 3 SBMs/week with at least 1 SBM/week increase over baseline.

Secondary Outcome Measures:

Response (responder/non-responder) to study drug in the LIR subgroup during Weeks 1 to 12, for at least 9 out of 12 weeks and at least 3 out of the last 4 weeks. [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
Responder is defined as having at least 3 SBMs/week, with at least 1 SBM/week increase over baseline.
Time (in hours) to first post-dose laxation without the use of rescue laxatives within the previous 24 hours. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Mean number of days per week with at least 1 SBM during Weeks 1 to 12. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	652
Study Start Date:	March 2011
Study Completion Date:	August 2012
Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Oral treatment	Drug: NKTR-118 12.5 mg oral tablet once daily
Experimental: 2 Oral treatment	Drug: NKTR-118 25 mg oral tablet once daily
Placebo Comparator: 3 Oral treatment	Drug: Placebo Oral tablet once daily

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.
Men and women who are between the ages of ≥18 and <85 years.
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 BMs over the previous 4 weeks); and Documented confirmed OIC (<3 SBMs/week on average over the 2-week OIC confirmation period.
Receiving 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 for a minimum of 4 weeks prior to screening for non-cancer-related pain with no anticipated change in opioid dose requirement over the proposed study period as a result of disease progression.
Willingness to stop all laxatives and other bowel regimens including prune juice and herbal products throughout the 2-week OIC confirmation period and the 12-week treatment period, and to use only bisacodyl as rescue medication if a 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 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: NCT01309841

Show 117 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Mark Sostek

AstraZeneca Pharmaceuticals, Wilm DE

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01309841 History of Changes
Other Study ID Numbers:	D3820C00004, 2011-001987-24
Study First Received:	March 4, 2011
Last Updated:	August 29, 2012
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration Germany: Federal Institute for Drugs and Medical Devices Slovakia: State Institute for Drug Control 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 June 17, 2013