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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

Study (07-IN-NX003) is a Phase 2, multi-center, placebo-controlled, double-blind, randomized, dose-escalation trial. It is designed to investigate the safety, efficacy and tolerability of NKTR-118 (PEG-naloxol) in patients with opioid-induced constipation (OIC) and other clinical manifestations of opioid-induced bowel dysfunction (OBD). The objective of this study is to evaluate the safety, effectiveness and pharmacokinetics of NKTR-118 at 4 different doses. The study is currently active and plans to enroll approximately 224 patients at about 50 sites in the US, Canada and the EU.

A Phase 2, Double-Blind, Multiple-Dose Escalation Study to Evaluate NKTR-118 (oral PEG-Naloxol) in Patients With Opioid-Induced Constipation (OIC)

5 mg, 25 mg, 50 mg or 100 mg, oral,once daily (QD)

Lifetree Clinical Research

PMI Health Research Group

Gold Coast Research LLC

ClinSearch, LLC

Southeast Clinical Research

Midwest Pharmaceutical Research, Inc.

Tennessee Valley Pain Consultants / Center for Pain Management

Therapeutic Research Institute of Orange County

Millennium Pain Center

Palm Beach Research Center

Four Seasons Hospice and Palliative Care

Gabrail Cancer Center

MAPS Applied Research Center

Arapahoe Gastroenterology, PC

Deerfoot Internal Medicine

Long Island Gastrointestinal Research Group

Osler Medical, Inc. / Osler Clinical Research

Options Health Research

Spokane Internal Medicine

Lovelace Scientific Resources, Inc.

Anderson Gastroenterology Associates, LLC

Singleton Health Center

San Diego Managed Care Group

Genova Clinical Research, Inc.

Pain Treatment Center of the Bluegrass

Pain & Rehabilitation Clinic of Chicago

Investigative Clinical Research of Indiana, LLC

The Center for Clinical Research, LLC

Northwest Clinical Trials

Riverhills Healthcare Research Division

Gulf Coast Reserach

Medford Medical Clinic

Centennial Medical Group

A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Multiple-Dose, Dose Escalation Study to Evaluate the Efficacy, Safety and Tolerability of NKTR-118 in Patients with Opioid-Induced Constipation (OIC)

Age Continuous

Gender, Male/Female

Race/Ethnicity, Customized

Baseline characteristics are summarized based on the MITT analysis population, which consisted of all randomized patients who received at least 1 dose of double-blind study treatment, had a baseline value and Visit 6 evaluable data (where Visit 6 was the Week 1 visit during the double-blind study treatment period).

Change from baseline in SBMs/week during Week 1 was defined as SBMs/week during the first week of double-blind study medication (between Visit 4 and Visit 6) minus baseline SBMs/week. Baseline was defined as the average SBMs/week during the 2-week OIC screening period. An SBM was defined as a BM without the use of laxatives in the previous 24 hours as recorded in the e-diary.

The MITT analysis population consisted of all randomized patients who received at least 1 dose of double-blind study treatment, had a baseline value and Visit 6 evaluable data (where Visit 6 was the Week 1 visit during the double-blind study treatment period).

Change from Baseline in Spontaneous Bowel Movements (SBMs) per week during Week 1

Change from baseline in SBMs/week across the 28-day double-blind period was calculated as SBMs/week during 28-day double-blind study treatment period minus baseline SBMs/week. Baseline was defined as the average SBMs/week during the 2-week OIC screening period.

Change from baseline in SBMs/week across the 28-day double-blind period

Physical Discomfort domain

Worries/Concerms domain

Psychosocial Discomfort domain

Satisfaction domain

Total Score

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). A negative change from baseline indicates improvement.

Change from Baseline in Patient Assessment of Constipation-Quality of Life (PAC-QOL) questionnaire

Abdominal Symptoms domain

Rectal Symptoms domain

Stool Symptoms domain

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. A negative change from baseline indicates improvement.

Change from baseline in Patient Assessment of Constipation-Symptoms (PAC-SYM) questionnaire

Single-blind placebo run-in period

Double-blind treatment period

Follow-up period

The study duration was up to 11 weeks, consisting of an initial screening period lasting up to 10 days, a 14-day OIC confirmation period, during which the OIC diagnosis was confirmed, a 7-day single-blind placebo run-in period, a 29-day double-blind treatment period, and a follow-up visit 2 weeks after the last dose of study drug.

Mark Sostek

Arms	Assigned Interventions
Placebo Comparator: A Placebo	Drug: placebo placebo, oral, once daily (QD)
Experimental: B NKTR-118	Drug: NKTR-118 5 mg, 25 mg, 50 mg or 100 mg, oral,once daily (QD)

A Phase 2, Double-Blind, Multiple-Dose Escalation Study to Evaluate NKTR-118 (oral PEG-Naloxol) in Patients With Opioid-Induced Constipation (OIC)

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

07-IN-NX003 CSR Synopsis.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator