Overview

This trial is active, not recruiting.

Condition constipation
Treatments sp-333 1 mg, sp-333 3 mg, sp-333 6 mg, placebo
Phase phase 2
Sponsor Synergy Pharmaceuticals Inc.
Start date November 2013
End date November 2014
Trial size 260 participants
Trial identifier NCT01983306, SP333201-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
1 mg SP-333 orally once daily for 4-week Treatment Period
sp-333 1 mg
Tablet
(Experimental)
3 mg SP-333 orally once daily for 4-week Treatment Period
sp-333 3 mg
Tablet
(Experimental)
6 mg SP-333 orally once daily for 4-week Treatment Period
sp-333 6 mg
Tablet
(Placebo Comparator)
Placebo orally once daily for 4-week Treatment Period
placebo
Tablet

Primary Outcomes

Measure
Change from baseline in the number of spontaneous bowel movements during Week 4 of the 4-week treatment period
time frame: 4 Weeks

Secondary Outcomes

Measure
To assess safety and tolerability of SP-333 in the treatment of non-malignant OIC
time frame: 4 weeks

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by Synergy Pharmaceuticals Inc..