The Effects of Tegaserod vs. Placebo on Whole Gut Transit Time in Patients With Chronic Constipation and Dyspepsia

Novartis

Status and phase: Withdrawn; Phase 4

Conditions: Constipation and Dyspepsia

Treatments: Drug: Tegaserod and Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00277550

CHTF919EUS42

Details and patient eligibility

About

To demonstrate the effects of tegaserod on gastrointestinal scintigraphic orocecal transit in female patients with CC and upper GI symptoms of dyspepsia

Sex: Female

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Females aged 18 to 64 years of age

• Patients must present with two or more of the following criteria for chronic constipation for at least 12 weeks prior to entering the study:

  1. Less than 3 bowel movements per week
  2. Hard or lumpy stools
  3. Straining during bowel movements
  4. Feeling of incomplete evacuation

• Patients must report overlapping symptoms consistent with dyspepsia, such as mid-upper abdominal discomfort characterized by early satiety, post-meal fullness and bloating

Exclusion criteria

• Patients with a recent history of, or current frequency of diarrhea occuring more than once per month off of laxatives

• Clinically significant diagnosis of pelvic outlet obstruction or pelvic floor dyssenergia as determined by the study physicians

• Patients with constipation secondary to medication use as determined by the study physician

• Patients with clinically significant abnormal TSH levels at screening

• Patients that have heartburn or abdominal pain as their predominant GI symptom

• Evidence of cathartic colon or a history of laxative abuse

  • Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind