Safety Study of LiRIS in Interstitial Cystitis (IC) Patients
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ClinicalTrials.gov Identifier: NCT01150565 |
Recruitment Status :
Completed
First Posted : June 25, 2010
Last Update Posted : November 25, 2014
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Condition or disease | Intervention/treatment | Phase |
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Interstitial Cystitis | Drug: LiRIS low dose and LiRIS high dose | Phase 1 |
Approximately 20 female patients with interstitial cystitis will be enrolled in this study at multiple centers in Canada. LiRIS is being developed to provide drug therapy directly into the urinary bladder. LiRIS contains Lidocaine, a marketed drug (approved by Health Canada) which is commonly used for local (skin or oral)anaesthesia. LiRIS is designed to release a controlled amount of lidocaine while in the bladder over a 2 week period.
Two dose groups of approximately 10 patients per group will be enrolled into the study; the first group of patients will receive low dose LiRIS, and the second group will receive high dose LiRIS. All patients receive LiRIS treatment for 14 days, and clinic follow-up at 7 and 14 days after treatment. Additional telephone follow-up occurs at approximately 6 and 10 weeks after LiRIS treatment. The maximum duration of participation, including a screening period of up to 14 days, will be 104 days.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 18 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Official Title: | Phase 1B Pilot Safety Study of LiRIS-TM, A Novel Bladder Drug Delivery Platform in Patients With Interstitial Cystitis |
Study Start Date : | July 2010 |
Actual Primary Completion Date : | September 2011 |
Actual Study Completion Date : | September 2011 |

Arm | Intervention/treatment |
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Experimental: LiRIS low dose
The first dose group of approximately 10 patients receive low dose LiRIS on Day 1 to Day 14.
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Drug: LiRIS low dose and LiRIS high dose
Drug delivery system containing lidocaine; LiRIS (low or high dose) is inserted into bladder via cystoscopy on Day 1 and removed via cystoscopy on Day 14. Designed to release lidocaine over a 14 day period. |
Experimental: LiRIS high dose
The second dose group of approximately 10 patients receive high dose LiRIS on Day 1 to Day 14.
|
Drug: LiRIS low dose and LiRIS high dose
Drug delivery system containing lidocaine; LiRIS (low or high dose) is inserted into bladder via cystoscopy on Day 1 and removed via cystoscopy on Day 14. Designed to release lidocaine over a 14 day period. |
- Cystoscopic examination [ Time Frame: Days 1 and 14 ]
- Bladder pain [ Time Frame: During and following treatment; study days 1 to 90 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Female patients ≥ 18 years of age
- If of child-bearing potential, agrees to use effective contraception defined by protocol
- Capable of understanding and completing symptom diaries and questionnaires as required in the study
- Diagnosed with IC, as defined by protocol criteria
Exclusion Criteria:
- Bladder or urethra anatomical feature that, in the opinion of the investigator, might prevent the safe placement, indwelling use, or removal of LiRIS
- History or presence of any medical condition that would interfere with ability to assess symptoms
- Pregnant or lactating patients

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01150565
Canada, British Columbia | |
Dr. Steinhoff Clinical Research | |
Victoria, British Columbia, Canada, V8V 3N1 | |
Canada, Nova Scotia | |
Queen Elizabeth II Health Sciences Centre, Halifax Infirmary | |
Halifax, Nova Scotia, Canada, B3H 3A7 | |
Canada, Ontario | |
Centre for Applied Urological Research | |
Kingston, Ontario, Canada, K7L 3J7 |
Principal Investigator: | Curtis Nickel, MD | Queen's University/Kingston General Hospital |
Responsible Party: | Allergan |
ClinicalTrials.gov Identifier: | NCT01150565 |
Other Study ID Numbers: |
TAR-100-103 |
First Posted: | June 25, 2010 Key Record Dates |
Last Update Posted: | November 25, 2014 |
Last Verified: | November 2014 |
Cystitis Cystitis, Interstitial Urinary Bladder Diseases Urologic Diseases |