Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility criteriaInclusion Criteria
- Able to communicate adequately with the investigator and to comply with the requirements for the entire study
- Meets Rome III criteria for functional constipation as assessed by questionnaires in period 1, i.e., report at least 2 of the following symptoms for last 3 months or more with symptom onset at least 6 months prior to diagnosis
- < 3 SBMs/week
- Hard or lumpy stools ≥ 25% of time
- Straining ≥ 25% of time
- Sense of incomplete evacuation ≥ 25% of time
- Feeling of anorectal blockage ≥ 25% of time
- Manual maneuvers to facilitate defecation ≥ 25% of time
- Patients who meet Rome III criteria for irritable bowel syndrome will also be eligible provided they also meet above criteria
Exclusion Criteria
- Current use of opioid analgesics
- Will be allowed to participate if they have discontinued them for at least 3 days (72 hrs.) before date of screening and are willing to stay off them for the duration of the study
- Current use of anticholinergics (e.g. nortriptyline, amitriptyline, hyoscyamine)
- Use of low dose tricyclic antidepressants (nortriptyline up to 50 mg/day or amitriptyline up to 25 mg/day ) will be eligible provided no increase in dose during the study period
- Higher doses or other anticholinergics are eligible if can discontinue medication at least 3 days (72 hrs) before the date of screening and willing to stay off them till the study is complete
- Current use of laxatives (MiraLax, Ex-lax, senna, herbal supplements), linaclotide, lubiprostone, and prucalopride to treat constipation will be eligible if can discontinue the medication at least 3 days (72 hrs.) before the date of screening and are willing to stay off them till the study is complete