Study to Evaluate the Safety and Efficacy of Naldemedine (S-297995) for the Treatment of Opioid-Induced Bowel Dysfunction in Subjects With Chronic Pain

NCT01122030 | Completed Phase 2 Results

• 1 other identifier: 1007V9214
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study is to evaluate the safety of single doses of oral naldemedine in adults physically dependent on opioids.

Conditions

Opioid Induced Bowel Dysfunction

Keywords

Chronic pain; Opioid physical dependence

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

  Severity of adverse events (AEs) was graded according to the following definitions: * Mild: The subject experiences awareness of symptoms but these are easily tolerated or managed without specific treatment * Moderate: The subject experiences discomfort enough to cause interference with usual activity, and/or the condition requires specific treatment * Severe: The subject is incapacitated with inability to work or do usual activity, and/or the event requires significant treatment measures. The relationship of the event to the study drug was determined by the investigator. A serious adverse event (SAE) is defined as any AE occurring at any dose that resulted in any of the following outcomes: death, life-threatening AE, hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect.

  From the first dose of study drug on Day 15 up to Day 24.

Secondary Outcomes (25)

• Change From Baseline to 24 Hours Post-dose in Number of Spontaneous Bowel Movements (SBMs) Per Day

  Baseline (Day 1 to Day 15) and Day 15 to 16 (0 to 24 hours post-dose)

• Change From Baseline to 48 Hours Post-dose in the Number of SBMs Per Day

  Baseline (Day 1 to Day 15) and Day 15 to Day 17 (0 to 48 hours post-dose)

• Change From Baseline to 24 Hours Post-dose in Number of Bowel Movements (BM) Per Day

  Baseline and 24 hours post-dose

• Change From Baseline to 48 Hours Post-dose in Number of Bowel Movements Per Day

  Baseline and 48 hours post-dose

• Change From Baseline to 24 Hours Post-dose in Number of Complete Spontaneous Bowel Movements (CSBMs) Per Day

  Baseline and 24 hours post-dose

Study Arms (6)

Cohort 1

EXPERIMENTAL

In this cohort 9 participants received one 0.1 mg naldemedine tablet and 3 participants received matching placebo administered on Day 15 under fasted conditions.

Drug: Naldemedine; Drug: Placebo

Cohort 2

EXPERIMENTAL

In this cohort 9 participants received a single dose of 0.3 mg naldemedine tablets and 3 participants received matching placebo tablets administered on Day 15 under fasted conditions.

Drug: Naldemedine; Drug: Placebo

Cohort 3

EXPERIMENTAL

In this cohort 9 participants received a single dose of 1 mg naldemedine tablets and 3 participants received matching placebo tablets administered on Day 15 under fasted conditions.

Drug: Naldemedine; Drug: Placebo

Cohort 4

EXPERIMENTAL

In this cohort 9 participants received a single dose of 3 mg naldemedine tablets and 3 participants received matching placebo tablets administered on Day 15 under fasted conditions.

Drug: Naldemedine; Drug: Placebo

Cohort 5

EXPERIMENTAL

In this cohort 9 participants received a single dose of 0.03 mg naldemedine oral solution and 3 participants received matching placebo oral solution administered on Day 15 under fasted conditions.

Drug: Naldemedine; Drug: Placebo

Cohort 6

EXPERIMENTAL

In this cohort 9 participants received a single dose of 0.01 mg naldemedine oral solution and 3 participants received matching placebo oral solution administered on Day 15 under fasted conditions.

Drug: Naldemedine; Drug: Placebo

Interventions

Naldemedine DRUG

Tablets or solution for oral administration

Also known as: S-297995, Symproic®

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6

Placebo DRUG

Tablets or solution for oral administration

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Understand and sign an informed consent form
• Males will agree to use an approved double-barrier method of contraception from Day 1 until 1 month after study completion
• Subject tests negative on urine drug test unless the subject has a prescription for the drug(s) that test positive

You may not qualify if:

• Subjects under opioid therapy for cancer-related pain or for the management of drug addiction
• Fecal incontinence, irritable bowel syndrome, inflammatory bowel disease, or other active medical disorders associated with diarrhea, intermittent loose stools, or constipation
• Subjects who have participated in any other investigational drug study within 30 days prior to Day 1
• Prior exposure to S-297995

Sponsors & Collaborators

• Shionogi: lead

Study Sites (1)

Shionogi Research Site

Salt Lake City, Utah, 84106, United States

Location

MeSH Terms

Conditions

Opioid-Induced Constipation; Chronic Pain

Interventions

naldemedine

Condition Hierarchy (Ancestors)

Constipation; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Pain; Neurologic Manifestations

Results Point of Contact

• Title: Shionogi Clinical Trials Administrator
• Organization: Shionogi Inc.

shionogiclintrials-admin@shionogi.co.jp

800-849-9707

Study Officials

• Shionogi Clinical Trials Administrator Clinical Support Help Line

  Shionogi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2010
• First Posted: May 12, 2010
• Study Start: May 19, 2010
• Primary Completion: February 23, 2011
• Study Completion: March 22, 2011
• Last Updated: May 30, 2017
• Results First Posted: May 30, 2017

Record last verified: 2011-09

Locations

US (1)