Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bausch Health Americas, Inc.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | Dose-ranging Study to Assess Safety and Efficacy of SP-333 for the Treatment of Opioid-induced Constipation (OIC)
