A clinical trial to study the effects of SPIRU-211 in chronic idiopathic constipation in the adult population.

Evaluation of efficacy and safety of SPIRU-211 in the treatment of chronic idiopathic constipation in the adult population: a randomized, double-blind, placebo-controlled, multi-center study.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000290

Enrollment

200

Registered

2010-04-01

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: SPIRU-211: One capsule BID for 4 weeks Control Intervention1: Placebo: One capsule BID for 4 weeks

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female patients aged between 18-70 years. 2. Patients having history of chronic constipation meeting Rome III diagnostic criteria. 3. Patients willing to give informed consent

Exclusion criteria

Exclusion criteria: 1. Pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control. 2. History of mechanical obstruction, mega colon/mega rectum or a diagnosis of pseudo obstruction. 3. Hospitalization for any gastrointestinal or abdominal surgical procedure during the 3 months before the start of the study. 4. Patients having clinically significant cardiovascular, liver, lung, or other systemic disease; neurologic or psychiatric disorders; impaired renal function.

Design outcomes

Primary

Measure	Time frame
? Consistency of Spontaneous bowel movement ? Number of Spontaneous bowel movement Timepoint: 4 weeks	—

Secondary

Measure	Time frame
? Need to strain while defecating ? Symptoms of abdominal bloating & discomfort ? Rescue medication Timepoint: 4 weeks	—

Countries

India

Contacts

Public ContactDr. Surendra Borgharkar

medical.services@sunpharma.com02266969696

Outcome results