Constipation
Conditions
Keywords
Constipation, Opioid, GC C Agonist, Pain
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.
Interventions
DRUGSP-333 1 mg
Tablet
DRUGSP-333 3 mg
Tablet
DRUGSP-333 6 mg
Tablet
DRUGPlacebo
Tablet
Sponsors
Bausch Health Americas, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the number of spontaneous bowel movements during Week 4 of the 4-week treatment period | 4 Weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| To assess safety and tolerability of SP-333 in the treatment of non-malignant OIC | 4 weeks | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| To evaluate stool consistency over the 4-week Treatment Period | 4 weeks | Compare SP-333 (1, 3 & 6 mg) with placebo in rates of change from baseline in stool consistency over the 4 weeks of treatment. |
| To evaluate constipation-related symptoms over the 4-week Treatment Period | 4 weeks | 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. |
| 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 | 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. |
Countries
United States
Outcome results
None listed