Trials / Completed
CompletedNCT02411110
A Safety and Efficacy Study of LiRIS® in Females With Interstitial Cystitis/Bladder Pain Syndrome
A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating Safety and Efficacy of LiRIS® 400 mg in Females With Interstitial Cystitis/Bladder Pain Syndrome
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 131 (actual)
- Sponsor
- Allergan · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a safety and efficacy study of LiRIS® in females with interstitial cystitis/bladder pain syndrome.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | LiRIS® | LiRIS® is a drug-device combination product which is placed in the bladder during cystoscopy and remains in the bladder, gradually releasing lidocaine until removed from the bladder via cystoscopy. |
| COMBINATION_PRODUCT | LiRIS Placebo | LiRIS placebo is a drug-device combination product, matching the LiRIS® which is placed in the bladder during cystoscopy, remains in the bladder until removed from the bladder via cystoscopy. |
Timeline
- Start date
- 2015-05-21
- Primary completion
- 2016-10-12
- Completion
- 2017-01-09
- First posted
- 2015-04-08
- Last updated
- 2018-01-04
- Results posted
- 2018-01-04
Locations
34 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02411110. Inclusion in this directory is not an endorsement.