Preference of Tegaserod vs. PEG 3350 in Patients With Constipation

Novartis

Status and phase: Completed; Phase 4

Conditions: Constipation

Treatments: Drug: Tegaserod and Polyethylene Glycol 3350

Study type: Interventional

Funder types: Industry

Identifiers

NCT00171522

CHTF919EUS49

Details and patient eligibility

About

To determine whether female patients have a preference for tegaserod of PEG 3350 relative to dosage form, convenience, ease of administration and taste

Sex: Female

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Females aged 18 to 64 years of age
• Patients with constipation as defined by the Rome II criteria

Exclusion criteria

• Patients who have been previously been treated with tegaserod and/or PEG 3350
• Evidence of cathartic colon or a history of laxative abuse or laxative dependence
• History of fecal impaction which necessitated surgical intervention
• Patients with clinically significant abnormal TSH levels at screening
• Women who are pregnant or breast feeding

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)