NCT01824303

Safety, Tolerability and Efficacy Study of LiRIS® 400 mg in Women With Interstitial Cystitis

A Phase 2 Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating Safety, Tolerability and Efficacy of LiRIS® 400 mg in Women With Interstitial Cystitis Followed by an Open Label Extension

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Allergan · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purposes of the study is to determine if LiRIS®, an investigational drug-delivery system, is safe and tolerable in women with Interstitial Cystitis (IC), and to evaluate any change in IC symptoms following LiRIS administration.

Detailed description

The study is conducted in 2 parts: a randomized, blinded part in which subjects are assigned randomly (by chance) to LiRIS 400 mg or LiRIS placebo; subjects who complete this part and are eligible to continue, may participate in the open-label part in which all subjects receive LiRIS 400 mg. In both parts of the study (blinded and open-label), LiRIS is inserted into the bladder during cystoscopy, remains in the bladder for 14 days, and is removed during cystoscopy. In addition to the 14 day period with the LiRIS/LiRIS Placebo, there is a screening period of up to 2 weeks and a follow up period of 4 weeks.

Conditions

• Interstitial Cystitis

Interventions

Type	Name	Description
DRUG	LiRIS 400 mg	LiRIS 400 mg contains lidocaine which is gradually released into the bladder over 14 days.
OTHER	LiRIS Placebo	LiRIS Placebo contains lactose, inactive substance.

Timeline

• Start date: 2013-03-01
• Primary completion: 2014-11-01
• Completion: 2014-12-01
• First posted: 2013-04-04
• Last updated: 2016-01-26
• Results posted: 2015-11-26

Locations

17 sites across 2 countries: United States, Canada