A Study To Investigate Tanezumab In Patients With Interstitial Cystitis/ Painful Bladder Syndrome

Phase 3

• Conditions: Health Condition 1: null- Cystitis, Interstitial

• Registration Number: CTRI/2010/091/000163
• Lead Sponsor: Pfizer Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Other (Terminated)
• Sex: Not specified
• Target Recruitment: 360

Inclusion Criteria

Ages Eligible for Study:18 Years and older,

Genders Eligible for Study:Both,

Accepts Healthy Volunteers:No

1. Patients with interstitial cystitis/ painful bladder syndrome for more than 6 months with moderate to severe pain and a micturition frequency greater than 7 per day.

2. Patients who have been on stable oral medicines for interstitial cystitis/ painful bladder syndrome for at least 3 months. Other therapies might need to be stopped

(there is no upper age limit for inclusion criteria for this trial)

Exclusion Criteria

1. Patients on certain recent treatments for interstitial cystitis/ painful bladder syndrome.

2. Body mass index (BMI) of greater than 39 kg per m2.

3.History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG-fusion protein.

4. Patients with peripheral neuropathy.

5. Patients with Type I or type II diabetes mellitus who have an HbA1c graeter than 8.0%.

Study & Design

• Study Type: Interventional
• Study Design: Not specified