Clinical trial NCT01983306: Dose-ranging Study to Assess Safety and Efficacy of SP-333 for the Treatment of Opioid-induced Constipation (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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Constipation
Keywords: Constipation
Opioid
GC C Agonist
Pain
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2013-11-13
Enrollment: 292
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in the number of spontaneous bowel movements during Week 4 of the 4-week treatment period
timeFrame: 4 Weeks
Secondary outcomes:
measure: To assess safety and tolerability of SP-333 in the treatment of non-malignant OIC
timeFrame: 4 weeks
Other outcomes:
measure: To evaluate stool consistency over the 4-week Treatment Period
timeFrame: 4 weeks
measure: To evaluate constipation-related symptoms over the 4-week Treatment Period
timeFrame: 4 weeks
measure: To evaluate bowel movement frequency responder rates [Complete Spontaneous Bowel Movements (CSBMs) and Spontaneous Bowel Movements (SBMs)] over the 4-week Treatment Period.
timeFrame: 4 weeks
Locations:
city: Huntsville
country: United States
facility: Synergy Research Site
state: Alabama
city: Mobile
country: United States
facility: Synergy Research Site
state: Alabama
city: Phoenix
country: United States
facility: Synergy Research Site
state: Arizona
city: Artesia
country: United States
facility: Synergy Research Site
state: California
city: Laguna Hills
country: United States
facility: Synergy Research Site
state: California
city: Oceanside
country: United States
facility: Synergy Research Site
state: California
city: Sacramento
country: United States
facility: Synergy Research Site
state: California
city: San Diego
country: United States
facility: Synergy Research Site
state: California
city: San Diego
country: United States
facility: Synergy Research Site
state: California
city: San Francisco
country: United States
facility: Synergy Research Site
state: California
city: Hialeah
country: United States
facility: Synergy Research Site
state: Florida
city: Miami Beach
country: United States
facility: Synergy Research Site
state: Florida
city: Miami
country: United States
facility: Synergy Research Site
state: Florida
city: Plant City
country: United States
facility: Synergy Research Site
state: Florida
city: Plantation
country: United States
facility: Synergy Research Site
state: Florida
city: Port Orange
country: United States
facility: Synergy Research Site
state: Florida
city: Sarasota
country: United States
facility: Synergy Research Site
state: Florida
city: West Palm Beach
country: United States
facility: Synergy Research Site
state: Florida
city: Winter Haven
country: United States
facility: Synergy Research Site
state: Florida
city: Atlanta
country: United States
facility: Synergy Research Site
state: Georgia
city: Bloomington
country: United States
facility: Synergy Research Site
state: Illinois
city: Traverse City
country: United States
facility: Synergy Research Site
state: Michigan
city: Saint Louis
country: United States
facility: Synergy Research Site
state: Missouri
city: Las Vegas
country: United States
facility: Synergy Research Site
state: Nevada
city: Great Neck
country: United States
facility: Synergy Research Site
state: New York
city: New York
country: United States
facility: Synergy Research Site
state: New York
city: Concord
country: United States
facility: Synergy Research Site
state: North Carolina
city: Greensboro
country: United States
facility: Synergy Research Site
state: North Carolina
city: Salisbury
country: United States
facility: Synergy Research Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Synergy Research Site
state: North Carolina
city: Dayton
country: United States
facility: Synergy Research Site
state: Ohio
city: Oklahoma City
country: United States
facility: Synergy Research Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Synergy Research Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Synergy Research Site
state: Oklahoma
city: Medford
country: United States
facility: Synergy Research Site
state: Oregon
city: Orangeburg
country: United States
facility: Synergy Research Site
state: South Carolina
city: Chattanooga
country: United States
facility: Synergy Research Site
state: Tennessee
city: Arlington
country: United States
facility: Synergy Research Site
state: Texas
city: Dallas
country: United States
facility: Synergy Research Site
state: Texas
city: Dallas
country: United States
facility: Synergy Research Site
state: Texas
city: Houston
country: United States
facility: Synergy Research Site
state: Texas
city: San Antonio
country: United States
facility: Synergy Research Site
state: Texas
Study officials:
affiliation: Synergy Pharmaceuticals Inc.
name: Renata Tenenbaum
role: STUDY_DIRECTOR
References: