Interstitial CystitisPhase 1NCT01150565
Safety Study of LiRIS in Interstitial Cystitis (IC) Patients
A Phase 1 study testing LiRIS low dose and LiRIS high dose in people with Interstitial Cystitis, run by Allergan at 3 sites in Canada.
Trial summary
The purpose of this study is primarily to evaluate the safety and tolerability of two dose levels of an investigational drug-delivery system (LiRIS) in patients who have moderate to severe symptoms of interstitial cystitis. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Interstitial Cystitis
- What is being tested?
- LiRIS low dose and LiRIS high dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 3 sitesCanada
- Study dates
- Jul 2010to Sep 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Queen Elizabeth II Health Sciences Centre, Halifax Infirmary
Halifax, Nova Scotia, B3H 3A7
Centre for Applied Urological Research
Kingston, Ontario, K7L 3J7
Dr. Steinhoff Clinical Research
Victoria, British Columbia, V8V 3N1
About this study
Official title: Phase 1B Pilot Safety Study of LiRIS-TM, A Novel Bladder Drug Delivery Platform in Patients With Interstitial Cystitis
The purpose of this study is primarily to evaluate the safety and tolerability of two dose levels of an investigational drug-delivery system (LiRIS) in patients who have moderate to severe symptoms of interstitial cystitis.
Read the detailed description
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.
- Conditions
- Interstitial Cystitis
- Being tested
- LiRIS low dose and LiRIS high dose
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiRIS low dose and LiRIS high doseDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| LiRIS low dose | Experimental | The first dose group of approximately 10 patients receive low dose LiRIS on Day 1 to Day 14. Receives: Drug: LiRIS low dose and LiRIS high dose |
| LiRIS high dose | Experimental | The second dose group of approximately 10 patients receive high dose LiRIS on Day 1 to Day 14. Receives: Drug: LiRIS low dose and LiRIS high dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cystoscopic examination
Measured: Days 1 and 14
Secondary outcomes (1)
Bladder pain
Measured: During and following treatment; study days 1 to 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2010 (estimated)
- Study startJul 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial CystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- TARIS Biomedical, Inc.
- Responsible party
- Sponsor
- Investigators
- Curtis Nickel, MD, Principal investigator, Queen's University/Kingston General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01150565
- Sponsor's protocol ID
- TAR-100-103
- Status last verified
- Nov 2014
- First submitted
- 23 Jun 2010
- Last updated
- 25 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1B Pilot Safety Study of LiRIS-TM, A Novel Bladder Drug Delivery Platform in Patients With Interstitial Cystitis
- ClinicalTrials.gov ID
- NCT01150565
- Acronym / sponsor ID
- TAR-100-103
- Conditions
- Interstitial Cystitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Collaborators
- TARIS Biomedical, Inc.
- Study start
- Jul 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 25 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is primarily to evaluate the safety and tolerability of two dose levels of an investigational drug-delivery system (LiRIS) in patients who have moderate to severe symptoms of interstitial cystitis.
Detailed description
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 design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LiRIS low dose | Experimental | Drug: LiRIS low dose and LiRIS high doseThe first dose group of approximately 10 patients receive low dose LiRIS on Day 1 to Day 14. |
| LiRIS high dose | Experimental | Drug: LiRIS low dose and LiRIS high doseThe second dose group of approximately 10 patients receive high dose LiRIS on Day 1 to Day 14. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiRIS low dose and LiRIS high doseDrug 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. | Drug | LiRIS high dose, LiRIS low dose |
Primary outcome
Cystoscopic examination
Time frame: Days 1 and 14
1 secondary outcome
Bladder pain
Time frame: During and following treatment; study days 1 to 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Curtis Nickel, MD principal investigator
Queen's University/Kingston General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LiRIS low dose and LiRIS high dose in people with Interstitial Cystitis, run by Allergan at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cystoscopic examination (time frame: Days 1 and 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2014.