Summary:
National, randomized, 12 week, double blind, placebo controlled study to assess safety and efficacy of plecanatide (3 and 6mg) in patients with chronic idiopathic constipation.
Three study arms and only one is placebo, so there is a greater chance of treatment
This study does allow for rescue medication (Ducolax) to be used if needed and provided by Sponsor
There are only 7 study visits needed with a stipend of $60 per visit
Sponsor will cover study meds, routine office visits/check ups, diet checks, serum chemistry, hematology, urinalysis labs and a colonoscopy pre-randomization if subject meets need criteria
Inclusion:
- Aged 18 to 80 years inclusive
- BMI needs to be 18-40(inclusive) provided no complications associated with morbid obesity
- Meet ROME III functional constipation criteria for at least 3 months prior to screening visit with symptom onset for least 6 months prior to diagnosis
- Loose stool rarely present without use of laxatives
- Doesn’t meet ROME III criteria for IBS-C
- Doesn’t use manual maneuvers
- Reports history of < 3 defecations/week
- Reports at least two of following: straining during ≥ 25% of defecations, lumpy/hard stool ≥ 25% defecations, sensation of incomplete evacuation ≥ 25% defecations, and/or sensation of anorectal obstruction/blockage ≥ 25% defecations
Exclusion:
- Pregnant of lactating females
- Not maintain stable diet 30days prior to screening or unwilling to maintain diet during study
- Major surgery (w/anesthesia) within 60days of screening
- History of malignancy within past 5 years
- HIV, HCV, HBV infections
- Stroke or MI in last 6 months
- Central nervous system condition that could cause constipation
- Subject cannot have history of pseudo-obstruction, megacolon, Hirschsprung’s disease, megarectum, bowel obstruction, descending perineum syndrome, solitary rectal ulcer syndrome, collagen vascular disease, or systemic sclerosis
- Must not have uncontrolled GERD or peptic ulcer disease, colon obstruction, GI tract abnormalities affecting motility, or grade 4 hemorrhoids needing surgical attention
- Cannot have had gastric bypass, current gastric bands, or abdominal/pelvic/retroperitoneal surgery within 6 months of screening
- History or presence of pseudo-obstruction, colon cancer, malignant polyps, colitis, ischemic colitis, abdominal adhesions, intestinal ischemia, or esophageal atresia; presence of acute anal fissures
- History of diverticulitis or other chronic condition that may be associated with chronic abdominal discomfort/pain within 2 years of screening (diverticulosis MAY be ok to randomize)
- Fecal impaction requiring hospital intervention within 3 months of screening
- History of eating disorder in last 5 years, cathartic colon, laxative/enema abuse, intestinal pseudo-obstruction, or pelvic floor dysfunction