Dose-ranging Study to Assess Safety and Efficacy of SP-333 for the Treatment of Opioid-induced Constipation (OIC)

Constipation Clinical Trial

— OIC  

Official title:

A Randomized, 4-Week, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Safety and Efficacy of SP-333 for the Treatment of Opioid-induced Constipation (OIC) in Patients With Non-malignant Chronic Pain Receiving Opioid Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01983306
• Other study ID #: SP333201-01
• Status: Completed
• Phase: Phase 2
• Start date: November 2013
• Est. completion date: April 2015

Study information

• Verified date: May 2021
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of a range of oral SP-333 doses for the treatment of opioid-induced constipation (OIC) in adults with non-cancer pain taking opioids.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 292
• Est. completion date: April 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Must be receiving chronic, stable opioid therapy to treat non-malignant pain for at least 3 months prior to screening

• Must have active OIC at screening

• Active OIC must be confirmed during baseline screening bowel habit and symptom diary

• Must be on stable diet

Exclusion Criteria:

• Has history of chronic therapy for chronic constipation prior to start of opioid therapy, or any potential non-opioid cause of bowel dysfunction that may be a major contributor to the constipation (i.e., mechanical obstruction or pseudo-obstruction)

• Use of medications that might affect bowel movement frequency or constipation-related symptoms (e.g., prokinetics, anti-diarrheal agents, laxatives other than study-defined rescue laxative)

• Has history of or current cancer (other than basal cell or squamous cell carcinoma of the skin) unless the malignancy has been in complete remission without maintenance chemotherapy for at least 5 years

• Unstable thyroid disease

Related Conditions & MeSH terms

• Constipation

Intervention

Drug:
• SP-333 1 mg
Tablet
• SP-333 3 mg
Tablet
• SP-333 6 mg
Tablet
• Placebo
Tablet

Locations

Country	Name	City	State
United States	Synergy Research Site	Arlington	Texas
United States	Synergy Research Site	Artesia	California
United States	Synergy Research Site	Atlanta	Georgia
United States	Synergy Research Site	Bloomington	Illinois
United States	Synergy Research Site	Chattanooga	Tennessee
United States	Synergy Research Site	Concord	North Carolina
United States	Synergy Research Site	Dallas	Texas
United States	Synergy Research Site	Dallas	Texas
United States	Synergy Research Site	Dayton	Ohio
United States	Synergy Research Site	Great Neck	New York
United States	Synergy Research Site	Greensboro	North Carolina
United States	Synergy Research Site	Hialeah	Florida
United States	Synergy Research Site	Houston	Texas
United States	Synergy Research Site	Huntsville	Alabama
United States	Synergy Research Site	Laguna Hills	California
United States	Synergy Research Site	Las Vegas	Nevada
United States	Synergy Research Site	Medford	Oregon
United States	Synergy Research Site	Miami	Florida
United States	Synergy Research Site	Miami Beach	Florida
United States	Synergy Research Site	Mobile	Alabama
United States	Synergy Research Site	New York	New York
United States	Synergy Research Site	Oceanside	California
United States	Synergy Research Site	Oklahoma City	Oklahoma
United States	Synergy Research Site	Oklahoma City	Oklahoma
United States	Synergy Research Site	Oklahoma City	Oklahoma
United States	Synergy Research Site	Orangeburg	South Carolina
United States	Synergy Research Site	Phoenix	Arizona
United States	Synergy Research Site	Plant City	Florida
United States	Synergy Research Site	Plantation	Florida
United States	Synergy Research Site	Port Orange	Florida
United States	Synergy Research Site	Sacramento	California
United States	Synergy Research Site	Saint Louis	Missouri
United States	Synergy Research Site	Salisbury	North Carolina
United States	Synergy Research Site	San Antonio	Texas
United States	Synergy Research Site	San Diego	California
United States	Synergy Research Site	San Diego	California
United States	Synergy Research Site	San Francisco	California
United States	Synergy Research Site	Sarasota	Florida
United States	Synergy Research Site	Traverse City	Michigan
United States	Synergy Research Site	West Palm Beach	Florida
United States	Synergy Research Site	Winston-Salem	North Carolina
United States	Synergy Research Site	Winter Haven	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To evaluate stool consistency over the 4-week Treatment Period	Compare SP-333 (1, 3 & 6 mg) with placebo in rates of change from baseline in stool consistency over the 4 weeks of treatment.	4 weeks
Other	To evaluate constipation-related symptoms over the 4-week Treatment Period	Compare SP-333 (1, 3 & 6 mg) with placebo in rates of change from baseline in constipation-related symptoms over the 4 weeks of treatment.	4 weeks
Other	To evaluate bowel movement frequency responder rates [Complete Spontaneous Bowel Movements (CSBMs) and Spontaneous Bowel Movements (SBMs)] over the 4-week Treatment Period.	Compare SP-333 (1, 3 & 6 mg) with placebo in rates of change from baseline for bowel movement frequency responder rates [Complete Spontaneous Bowel Movements (CSBMs) and Spontaneous Bowel Movements (SBMs)] over the 4 weeks of treatment.	4 weeks
Primary	Change from baseline in the number of spontaneous bowel movements during Week 4 of the 4-week treatment period	Compare SP-333 (1, 3 & 6 mg) with placebo in the treatment of OIC as measured by the change from baseline in the number of spontaneous bowel movements during Week 4 of the 4-week treatment period	4 Weeks
Secondary	To assess safety and tolerability of SP-333 in the treatment of non-malignant OIC	Compare the safety and tolerability of SP-333 (1, 3 & 6 mg) with placebo as measured by rates of adverse events, clinical laboratory abnormalities and significant changes in vital signs and ECGs.	4 weeks