Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-24 @ 3:56 PM
NCT ID:
NCT01827592
Eligibility Criteria:
Inclusion Criteria:
* Body mass index (BMI) ≥18.5 but \<35.0 kg/m\^2
* Male or female ≥18 years of age
* Reports \<3 spontaneous Bowel movements (BM) per week and reports one or more of the following symptoms for the last 3 months with symptom onset at least 6 months before the Screening Visit or before starting chronic therapy with any laxative:
1. Straining during at least 25% of defecations
2. Lumpy or hard stools during at least 25% of defecations
3. Sensation of incomplete evacuation during at least 25% of defecations
* Is ambulatory and community dwelling
* An initial colonoscopy is required if recommended by national guidelines
Exclusion Criteria:
* Reports loose (mushy) or watery stools in the absence of any laxative intake in the form of a tablet, a suppository or an enema, or prohibited medicine for \>25% of BMs
* The patient reports a BSFS of 6 or 7 during the Pretreatment Period
* Has irritable bowel syndrome (IBS) with pain/discomfort as predominant symptoms
* Has a structural abnormality of the GI tract or a disease or condition that can affect Gastrointestinal (GI) motility
* Has a history of diverticulitis, chronic pancreatitis, active peptic ulcer disease (PUD) not adequately treated, ischaemic colitis, inflammatory bowel disease, laxative abuse, faecal impaction that required hospitalization or emergency treatment, pseudo-obstruction, megacolon, megarectum, bowel obstruction, descending perineum syndrome, ovarian cysts, endometriosis, solitary rectal ulcer syndrome, systemic sclerosis, pre-malignant colonic disease (e.g., familial adenomatous polyposis or hereditary non-polyposis colorectal cancer) or other forms of familial colorectal cancer.
* Has unexplained and clinically significant GI alarm signals (e.g., lower GI bleeding or heme-positive stool in the absence of known internal or external haemorrhoids, iron-deficiency anaemia, unexplained weight loss) or systemic signs of infection or colitis
* Has a potential central nervous system (CNS) cause of constipation (e.g., Parkinson's disease, spinal cord injury, multiple sclerosis)
* Has intestinal/rectal prolapse or other known pelvic floor dysfunction
* Commonly uses digital manoeuvres (perianal pressure or digital disimpaction) or vaginal splinting to facilitate the passage of a bowel movement
* Has a history of diabetic neuropathy
* Has a history of bariatric surgery for treatment of obesity; surgery to remove a segment of the GI tract; or surgery of the abdomen, pelvic or retroperitoneal area during the 6 months prior to Screening; or appendectomy or cholecystectomy 3 months prior to screening; or other major surgery 1 month prior to Screening
* Has a history of cancer with last date of proven disease activity/presence of malignancy within 5 years, except for adequately treated basal cell carcinoma of the skin, cervical dysplasia, or carcinoma in situ of the skin or the cervix
* Known human immunodeficiency virus (HIV) or Hepatitis B/C (HBV/HCV) infection
* Has a history of hospitalization for any psychiatric disorder, or any suicide attempt in the 2 years prior to Screening
* Is actively abusing alcohol or drugs or has a history of alcohol or drug abuse during the 6 months prior to Screening
* Is being treated for hypothyroidism, but the dose of medication has not been stable for at least 3 months at the time of Screening
* Is a pregnant, breast-feeding, or lactating woman
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01827592
Study Brief:
Protocol Section:
NCT01827592