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

Primary Purpose

Constipation

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SP-333 1 mg
SP-333 3 mg
SP-333 6 mg
Placebo
Sponsored by
Bausch Health Americas, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation focused on measuring Constipation, Opioid, GC C Agonist, Pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Synergy Research Site
  • Synergy Research Site
  • Synergy Research Site
  • Synergy Research Site
  • Synergy Research Site
  • Synergy Research Site
  • Synergy Research Site
  • Synergy Research Site
  • Synergy Research Site
  • Synergy Research Site
  • Synergy Research Site
  • Synergy Research Site
  • Synergy Research Site
  • Synergy Research Site
  • Synergy Research Site
  • Synergy Research Site
  • Synergy Research Site
  • Synergy Research Site
  • Synergy Research Site
  • Synergy Research Site
  • Synergy Research Site
  • Synergy Research Site
  • Synergy Research Site
  • Synergy Research Site
  • Synergy Research Site
  • Synergy Research Site
  • Synergy Research Site
  • Synergy Research Site
  • Synergy Research Site
  • Synergy Research Site
  • Synergy Research Site
  • Synergy Research Site
  • Synergy Research Site
  • Synergy Research Site
  • Synergy Research Site
  • Synergy Research Site
  • Synergy Research Site
  • Synergy Research Site
  • Synergy Research Site
  • Synergy Research Site
  • Synergy Research Site
  • Synergy Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

SP-333 1 mg

SP-333 3 mg

SP-333 6 mg

Placebo

Arm Description

1 mg SP-333 orally once daily for 4-week Treatment Period

3 mg SP-333 orally once daily for 4-week Treatment Period

6 mg SP-333 orally once daily for 4-week Treatment Period

Placebo orally once daily for 4-week Treatment Period

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
October 29, 2013
Last Updated
May 4, 2021
Sponsor
Bausch Health Americas, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01983306
Brief Title
Dose-ranging Study to Assess Safety and Efficacy of SP-333 for the Treatment of Opioid-induced Constipation (OIC)
Acronym
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

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch Health Americas, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
Constipation, Opioid, GC C Agonist, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
292 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SP-333 1 mg
Arm Type
Experimental
Arm Description
1 mg SP-333 orally once daily for 4-week Treatment Period
Arm Title
SP-333 3 mg
Arm Type
Experimental
Arm Description
3 mg SP-333 orally once daily for 4-week Treatment Period
Arm Title
SP-333 6 mg
Arm Type
Experimental
Arm Description
6 mg SP-333 orally once daily for 4-week Treatment Period
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo orally once daily for 4-week Treatment Period
Intervention Type
Drug
Intervention Name(s)
SP-333 1 mg
Intervention Description
Tablet
Intervention Type
Drug
Intervention Name(s)
SP-333 3 mg
Intervention Description
Tablet
Intervention Type
Drug
Intervention Name(s)
SP-333 6 mg
Intervention Description
Tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablet
Primary Outcome Measure Information:
Title
Change from baseline in the number of spontaneous bowel movements during Week 4 of the 4-week treatment period
Description
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
Time Frame
4 Weeks
Secondary Outcome Measure Information:
Title
To assess safety and tolerability of SP-333 in the treatment of non-malignant OIC
Description
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.
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
To evaluate stool consistency over the 4-week Treatment Period
Description
Compare SP-333 (1, 3 & 6 mg) with placebo in rates of change from baseline in stool consistency over the 4 weeks of treatment.
Time Frame
4 weeks
Title
To evaluate constipation-related symptoms over the 4-week Treatment Period
Description
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.
Time Frame
4 weeks
Title
To evaluate bowel movement frequency responder rates [Complete Spontaneous Bowel Movements (CSBMs) and Spontaneous Bowel Movements (SBMs)] over the 4-week Treatment Period.
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renata Tenenbaum
Organizational Affiliation
Synergy Pharmaceuticals Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Synergy Research Site
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Synergy Research Site
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Synergy Research Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Synergy Research Site
City
Artesia
State/Province
California
ZIP/Postal Code
90701
Country
United States
Facility Name
Synergy Research Site
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Synergy Research Site
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Synergy Research Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95831
Country
United States
Facility Name
Synergy Research Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Synergy Research Site
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Synergy Research Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94103
Country
United States
Facility Name
Synergy Research Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Synergy Research Site
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Synergy Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Synergy Research Site
City
Plant City
State/Province
Florida
ZIP/Postal Code
33563
Country
United States
Facility Name
Synergy Research Site
City
Plantation
State/Province
Florida
ZIP/Postal Code
33317
Country
United States
Facility Name
Synergy Research Site
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32129
Country
United States
Facility Name
Synergy Research Site
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Synergy Research Site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Synergy Research Site
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
Synergy Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30312
Country
United States
Facility Name
Synergy Research Site
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61701
Country
United States
Facility Name
Synergy Research Site
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
Facility Name
Synergy Research Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Synergy Research Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Synergy Research Site
City
Great Neck
State/Province
New York
ZIP/Postal Code
11023
Country
United States
Facility Name
Synergy Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Synergy Research Site
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
Facility Name
Synergy Research Site
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
Synergy Research Site
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Synergy Research Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Synergy Research Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45424
Country
United States
Facility Name
Synergy Research Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73101
Country
United States
Facility Name
Synergy Research Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Synergy Research Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73119
Country
United States
Facility Name
Synergy Research Site
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Synergy Research Site
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
Synergy Research Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Synergy Research Site
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Synergy Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75218
Country
United States
Facility Name
Synergy Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Synergy Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Facility Name
Synergy Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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