A Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Lubiprostone Soft Gelatin capsules 24 mcg Vs Bisacodyl tablet 10 mg in the patients with chronic constipation.

A comparative, randomized, open label, parallel group, multicentric, clinical study to Evaluate the Efficacy, Safety and Tolerability of Lubiprostone Soft Gelatin capsules 24 mcg Vs Bisacodyl tablet 10 mg in the patients with chronic constipation.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000586

Enrollment

200

Registered

2010-06-07

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

Health Condition 1: null- chronic constipation Health Condition 2: K928- Other specified diseases of the digestive system

Interventions

Intervention1: Lubiprostone Soft Gelatin capsules 24 mcg: One capsule twice daily for 4 week Control Intervention1: Bisacodyl Tablet 10 mg: Once daily for 4 week

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient with clinical diagnosis of chronic constipation 2. Written informed consent by patient participating in the trial

Exclusion criteria

Exclusion criteria: 1. Adult patients <18 years of age of either sex 2. History of hypersensitivity to the study drug or related products 3. Significant history or presence of gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of common medications 4. Any clinical significant illness during the 1 week prior to day 1 of this study 5. Participation in a clinical trial with an investigation drug within 30 days proceeding day 1 of this study 6. Any condition that, in the opinion of the investigator, does not justify the patient?s inclusion in the study

Design outcomes

Primary

Measure	Time frame
Patients having three or more spontaneous complete bowel movements per weekTimepoint: 0th Day, 1st Week, 2nd Week, 3rd Week, 4th Week	—

Secondary

Measure	Time frame
Bowel movementTimepoint: 0th Day, 1st Week, 2nd Week, 3rd Week, 4th Week;Faecal strainingTimepoint: 0th Day, 1st Week, 2nd Week, 3rd Week, 4th Week;Global AssessmentTimepoint: 4th Week;Percentage of bowel movement with normal consistencyTimepoint: 0th Day, 1st Week, 2nd Week, 3rd Week, 4th Week;Percentage of patient with an average increase of SCBM per weekTimepoint: 0th Day, 1st Week, 2nd Week, 3rd Week, 4th Week;Safety and TolerabilityTimepoint: 0th Day, 1st Week, 2nd Week, 3rd Week, 4th Week;Score of Abdominal PainTimepoint: 0th Day, 1st Week, 2nd Week, 3rd Week, 4th Week;status of fecesTimepoint: 0th Day, 1st Week, 2nd Week, 3rd Week, 4th Week	—

Measure

Time frame

Bowel movementTimepoint: 0th Day, 1st Week, 2nd Week, 3rd Week, 4th Week;Faecal strainingTimepoint: 0th Day, 1st Week, 2nd Week, 3rd Week, 4th Week;Global AssessmentTimepoint: 4th Week;Percentage of bowel movement with normal consistencyTimepoint: 0th Day, 1st Week, 2nd Week, 3rd Week, 4th Week;Percentage of patient with an average increase of SCBM per weekTimepoint: 0th Day, 1st Week, 2nd Week, 3rd Week, 4th Week;Safety and TolerabilityTimepoint: 0th Day, 1st Week, 2nd Week, 3rd Week, 4th Week;Score of Abdominal PainTimepoint: 0th Day, 1st Week, 2nd Week, 3rd Week, 4th Week;status of fecesTimepoint: 0th Day, 1st Week, 2nd Week, 3rd Week, 4th Week

—

Countries

India

Contacts

Public ContactDr Shailesh Singh

Ajanta Pharma Ltd, Advent

shailesh.singh@ajantapharma.com02266062111

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026