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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Constipation

Intervention / Treatment
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* Drug: SP-333 1 mg
* Drug: SP-333 3 mg
* Drug: SP-333 6 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SP-333 1 mg<br>1 mg SP-333 orally once daily for 4-week Treatment Period | Drug: SP-333 1 mg<br>* Tablet<br>|
| Experimental: SP-333 3 mg<br>3 mg SP-333 orally once daily for 4-week Treatment Period | Drug: SP-333 3 mg<br>* Tablet<br>|
| Experimental: SP-333 6 mg<br>6 mg SP-333 orally once daily for 4-week Treatment Period | Drug: SP-333 6 mg<br>* Tablet<br>|
| Placebo Comparator: Placebo<br>Placebo orally once daily for 4-week Treatment Period | Drug: Placebo<br>* Tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Constipation, Opioid, GC C Agonist, Pain