Summary:
Innovative Medical Research of South Florida is conducting a research study for individuals with Chronic Idiopathic Constipation.
To evaluate the efficacy and safety of 3.0 and 6.0 mg of plecanitide administered once daily for 12 weeks in a population of patients with CIC.
Patients will be entered into the study only if they meet all of the following criteria: Willingness to Participate and General Good Health
- Patient is willing and able to participate in the study for required duration, can understand and is willing to sign the ICF and agrees to undergo all protocol-related tests and procedures.
- Patient is able to complete all required Daily BM and Symptom electronic diary entries during the 2-week Pre-Treatment assessment period and for the duration of the study (i.e., the 12-week Treatment Period and the 2-week Post-Treatment Period). Patient must agree to receive a reminder daily via their electronic hand-held device (EHD) should they not complete their daily electronic diary entries.
- Males or females between 18 and 80 years of age. Females must not be pregnant or lactating.
- Patient has BMI between 180 and 40kg/m2 inclusive provided the patient does not have medical complications associated with morbid obesity.
- Female patients of non-childbearing potential who are surgically sterile or post-menopausal. To be considered post-menopausal female patients must be without menses for 12 consecutive months before screening and have an elevated FSH with consistent with menopause.
- Females who are still menstruating must be able to differentiate the abdominal symptoms associated with CIC from those associated with their menses.
- Male and female patients of child-bearing potential must agree to use one of the following methods of birth control form the time of signing the ICF to 2 weeks after receiving the last dose of study drug.
- Patient meets the Rome III functional constipation criteria as modified for this study for at least 3 months prior to the screening visit with symptom onset for at least 6 moths prior to the diagnosis.
- The Rome III criteria as modified for this study require the following:
- patient reports that loose stool is rarely present without the use of laxatives.
- patient does not meet the Rome III criteria for IBS-C
- patient does not use manual maneuvers to facilitate defecations
- patient reports a history of <3 defecations per week
- patient reports at least two of the following:
- Straining during at least 25% of defecations
- Lumpy or hard stool in at least 25% of defecations
- Sensation of incomplete evacuation for at least 25% of defecations
- Sensation of anorectal obstruction/blockage for at least 25% of defecations
- Patients who meet the modified Rome III criteria based on history must also demonstrate the following during the two-week Pre-Treatment EHD assessment period:
- < 3 CSBMs each week
- BSFS of 6 or 7 in less than 25% of SBMs
- One out of the following three (a,b,c):
- BSFS of 1 or 2 in at least 25% of defecations
- A straining value recorded on at least 25% of days when a BM was reported
- At least 25% of BMs result in a sense of incomplete evacuation