Dose-ranging Study to Assess Safety and Efficacy of SP-333 for the Treatment of Opioid-induced Constipation (OIC)
OIC
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
1 other identifier
interventional
292
1 country
42
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2013
Shorter than P25 for phase_2
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2013
CompletedStudy Start
First participant enrolled
November 1, 2013
CompletedFirst Posted
Study publicly available on registry
November 13, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedMay 7, 2021
May 1, 2021
10 months
October 29, 2013
May 4, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
To assess safety and tolerability of SP-333 in the treatment of non-malignant OIC
4 weeks
Other Outcomes (3)
To evaluate stool consistency over the 4-week Treatment Period
4 weeks
To evaluate constipation-related symptoms over the 4-week Treatment Period
4 weeks
To evaluate bowel movement frequency responder rates [Complete Spontaneous Bowel Movements (CSBMs) and Spontaneous Bowel Movements (SBMs)] over the 4-week Treatment Period.
4 weeks
Study Arms (4)
SP-333 1 mg
EXPERIMENTAL1 mg SP-333 orally once daily for 4-week Treatment Period
SP-333 3 mg
EXPERIMENTAL3 mg SP-333 orally once daily for 4-week Treatment Period
SP-333 6 mg
EXPERIMENTAL6 mg SP-333 orally once daily for 4-week Treatment Period
Placebo
PLACEBO COMPARATORPlacebo orally once daily for 4-week Treatment Period
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (42)
Synergy Research Site
Huntsville, Alabama, 35801, United States
Synergy Research Site
Mobile, Alabama, 36608, United States
Synergy Research Site
Phoenix, Arizona, 85018, United States
Synergy Research Site
Artesia, California, 90701, United States
Synergy Research Site
Laguna Hills, California, 92653, United States
Synergy Research Site
Oceanside, California, 92056, United States
Synergy Research Site
Sacramento, California, 95831, United States
Synergy Research Site
San Diego, California, 92103, United States
Synergy Research Site
San Diego, California, 92108, United States
Synergy Research Site
San Francisco, California, 94103, United States
Synergy Research Site
Hialeah, Florida, 33012, United States
Synergy Research Site
Miami, Florida, 33173, United States
Synergy Research Site
Miami Beach, Florida, 33140, United States
Synergy Research Site
Plant City, Florida, 33563, United States
Synergy Research Site
Plantation, Florida, 33317, United States
Synergy Research Site
Port Orange, Florida, 32129, United States
Synergy Research Site
Sarasota, Florida, 34239, United States
Synergy Research Site
West Palm Beach, Florida, 33409, United States
Synergy Research Site
Winter Haven, Florida, 33880, United States
Synergy Research Site
Atlanta, Georgia, 30312, United States
Synergy Research Site
Bloomington, Illinois, 61701, United States
Synergy Research Site
Traverse City, Michigan, 49684, United States
Synergy Research Site
St Louis, Missouri, 63117, United States
Synergy Research Site
Las Vegas, Nevada, 89102, United States
Synergy Research Site
Great Neck, New York, 11023, United States
Synergy Research Site
New York, New York, 10016, United States
Synergy Research Site
Concord, North Carolina, 28025, United States
Synergy Research Site
Greensboro, North Carolina, 27403, United States
Synergy Research Site
Salisbury, North Carolina, 28144, United States
Synergy Research Site
Winston-Salem, North Carolina, 27103, United States
Synergy Research Site
Dayton, Ohio, 45424, United States
Synergy Research Site
Oklahoma City, Oklahoma, 73101, United States
Synergy Research Site
Oklahoma City, Oklahoma, 73104, United States
Synergy Research Site
Oklahoma City, Oklahoma, 73119, United States
Synergy Research Site
Medford, Oregon, 97504, United States
Synergy Research Site
Orangeburg, South Carolina, 29118, United States
Synergy Research Site
Chattanooga, Tennessee, 37421, United States
Synergy Research Site
Arlington, Texas, 76012, United States
Synergy Research Site
Dallas, Texas, 75218, United States
Synergy Research Site
Dallas, Texas, 75231, United States
Synergy Research Site
Houston, Texas, 77081, United States
Synergy Research Site
San Antonio, Texas, 78209, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Renata Tenenbaum
Synergy Pharmaceuticals Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2013
First Posted
November 13, 2013
Study Start
November 1, 2013
Primary Completion
September 1, 2014
Study Completion
April 1, 2015
Last Updated
May 7, 2021
Record last verified: 2021-05