Opioid-Induced Constipation

Lotus Clinical Research has successfully completed multiple OIC investigations both as a research site and as a CRO. We are recognized nationally for our work in OIC. Because of our extensive experience, Lotus Clinical Research has the ability to advise its clients on issues that will be critical to the success of any OIC investigations, including:

• Expected run-in failure rate based on study specific inclusion/exclusion criteria
• Techniques to improve subject diary compliance
• Subject training to improve reporting consistency around Spontaneous Bowel Movements (SBMs)
• Subject training on the Bristol stool scale
• Methods to rate/adjudicate CNS adverse events

Clinical Opioid Withdrawal Scale (COWS)

Lotus Clinical Research has developed a proprietary training tool for study investigators around the proper performance of the COWS. The system involves video training and several post-training vignettes. Test results are scored and retained in the study site regulatory binder.

Database

Lotus Clinical Research has the nation’s largest OIC database consisting of over 12,000 study volunteers with chronic pain. The database is mature, well maintained, and sortable for criteria specific to OIC studies, such as: total daily morphine mEq intake, historical weekly bowel movement frequency, and pain etiology.

CNS & Gastrointestinal Adverse Event Adjudication

Properly evaluating central and gastrointestinal withdrawal symptoms requires not only training but also a significant amount of experience. At Lotus Clinical Research, we have enrolled hundreds of patients into OIC trials, which ensures our physicians, allied health professionals, and study coordinators have the requisite knowledge to accurately evaluate and adjudicate OIC related adverse events.

Gastrointestinal withdrawal symptoms can range from mild and tolerable to severe and disabling. In many early phase protocols, severe GI symptoms are an MTD criteria, making appropriate assessment of GI AEs even more critical. CNS withdrawal is a safety concern for any opioid antagonist. Beyond understanding how to conduct COWs and SOWs questionnaires, the site must also ensure that the patient has adequate opioid reserves so their baseline opioid intake is not disrupted. These disruptions can lead to inadvertent withdrawal not related to the study medication, which can confound study results.