A clinical Trial in-patients suffering from Overactive Bladder. Clinical trial is to study efficacy, safety and tolerability of Imidafenacin Tablets 0.1 mg in comparison to Uritos Tablets (reference product).

A comparative, single blind, parallel group, non-crossover, multi-centric trial of Imidafenacin Tablets 0.1 mg, with Uritos Tablets, in-patients suffering from Overactive Bladder.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000820

Enrollment

200

Registered

2009-10-28

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: N33- Bladder disorders in diseases classified elsewhere Health Condition 2: null- Overactive Bladder

Interventions

Intervention1: Imidafenacin Tablets 0.1 mg: Two Tablets per day for 8 week Control Intervention1: Uritos Tablets: Two Tablets per day for 8 weeks

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male and female patients between 18 and 60 years of age 2. Availability of subjects for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent. 3. Patient with signs and symptoms of Overactive Bladder, diagnosed clinically.

Exclusion criteria

Exclusion criteria: 1. Patients <18 & > 60 years. 2. Pregnant or lactating women. 3. Patients with hypersensitivity to the drug. 4. Concomitant illness 5. Patients who have participated in a drug study in the past 3 months. 6. Any condition which are likely to hinder the compliance with the protocol.

Design outcomes

Primary

Measure	Time frame
A comparative evaluation of efficacy of Imidafenacin Tablets 0.1 mg, with Uritos Tablets, in-patients suffering from Overactive Bladder. The efficacy parameters will primarily focus on improvement in the clinical signs & symptoms like Frequent urination, Urgency of urination and Urge incontinence.Timepoint: Day 0, Week 1, Week 2, Week 4, 6 Week and 8 Week.	—

Secondary

Measure	Time frame
A comparative evaluation of safety & tolerability of Imidafenacin Tablets 0.1 mg, with Uritos Tablets, in-patients suffering from Overactive Bladder.Timepoint: Day 0, Week 1, Week 2, Week 4, 6 Week and 8 Week.	—

Countries

India

Contacts

Public ContactDr Shailesh Singh

Ajanta Pharma Ltd, Advent

shaileshs@ajantapharma.com022-66062112

Outcome results

None listed

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