Birmingham, Alabama (PRWEB) August 27, 2013
*To see if you qualify for this Constipation Clinical Trial in Alabama, visit Achieve Clinical Research on the web (http://www.achieveclinical.com) or contact us directly at (205) 380-6434. There is no cost to participate, no insurance is required, and you may receive compensation for time and travel.
This is a multicenter, double-blind, placebo-controlled, parallel-group study in participants with opioid-induced constipation who are taking opioid therapy for chronic non-cancer pain. Participants will be randomized in a 1:1 ratio to receive the new constipation drug or matching placebo. The study will consist of 3 periods: a screening period of up to 21 days, a 52-week double-blind treatment period, and a 4-week follow-up period.
BACKGROUND & RATIONALE
Patients who take opioids often suffer from constipation and associated gastrointestinal side effects (e.g., abdominal cramping, abdominal bloating, excess gas) for as long as they remain on opioid therapy. Based on the reported literature and previous clinical trials, these patients often suffer from constipation for many years thus requiring long-term management for this condition.
Opioid-induced constipation has a negative impact on a patient’s quality of life and, if not treated effectively, can lead to serious complications including obstipation and bowel perforation. Moreover, patients may discontinue opioids because of the associated constipation, thereby compromising their pain management and increasing the risk of systemic opioid withdrawal.
No drug has been approved as monotherapy for the treatment of constipation in patients taking opioid therapy for chronic non-cancer pain. Current treatment options are limited: they include stool softeners and laxatives; diet and exercise; and opioid dose-reduction, switching, or discontinuation. However, these treatments are often ineffective, associated with significant GI side effects, and burdensome to patients.
Evaluate the safety and tolerability of this experimental constipation drug in human participants over 12 months, relative to a placebo.
To be eligible for enrollment, a subject must meet all of the following criteria before any study-related procedures are conducted:
*Achieve Clinical Research conducts Phase II-IV Clinical Trials in Alabama. For more information about participating in a Constipation Clinical Study, please visit our website or contact us directly at (205) 380-6434.