Interstitial CystitisPhase 2NCT01824303
Safety, Tolerability and Efficacy Study of LiRIS® 400 mg in Women With Interstitial Cystitis
A Phase 2 study testing LiRIS 400 mg in people with Interstitial Cystitis, run by Allergan at 17 sites in 2 countries.
Trial 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. 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 400 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 17 sitesin 2 countries
- Study dates
- Mar 2013to Dec 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Blinded study:
- Women age 18 and over
- Diagnosed with Interstitial Cystitis as defined by protocol
- Able to report IC symptoms of bladder pain, voiding habits, as required by protocol, and record in diary
- Able to comply with visit schedule and diary completion at home
- Open-label Extension:
- Must have completed the blinded study prior to screening for the Open-label extension
Who cannot join
- Pregnant or lactating women
- History or presence of any condition that would make it difficult to accurately evaluate bladder symptoms
- Bladder or urethral abnormality that would prevent safe insertion of investigational product
- Requiring medication not allowed per study protocol
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
United States15 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
MetroHealth Medical Center
Cleveland, Ohio, 44109
Atlantic Urological Associates
Daytona Beach, Florida, 32114
Citrus Valley Medical Research , Inc.
Glendora, California, 91741
Female Pelvic Medicine & Urogynecology Institute of MI
Grand Rapids, Michigan, 49503
Alliance Urology Specialists, PA
Greensboro, North Carolina, 27403
University of Kansas Medical Center
Kansas City, Kansas, 66160
Volunteer Research Group, University of Tennessee Medical Center
Knoxville, Tennessee, 37920
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
North Shore - Long Island Jewish Heath System - Monter Cancer Center
New Hyde Park, New York, 11040
Premier Medical Group of the Hudson Valley PC
Newburgh, New York, 12550
The UrogynecologyCenter, LLC
Overland Park, Kansas, 66209-2002
Premier Medical Group of the Hudson Valley PC
Poughkeepsie, New York, 12601
William Beaumont Hospitals
Royal Oak, Michigan, 48073
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27103
Canada2 sites
Exdeo Clinical Research Inc.
Abbotsford British Columbia, British Columbia, V2S 3N6
Centre for Applied Urological Research
Kingston, Ontario, K7L 3J7
About this study
Official title: 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
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.
Read the 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
- Being tested
- LiRIS 400 mg, LiRIS Placebo
- 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 400 mgDrug
LiRIS 400 mg contains lidocaine which is gradually released into the bladder over 14 days.
LiRIS PlaceboOther
LiRIS Placebo contains lactose, inactive substance.
| Study group | Role | What they receive |
|---|---|---|
| LiRIS 400 mg | Experimental | LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days. If eligible, participants could participate in the Open Label Extension where all participants were treated with LiRIS 400 mg. Receives: Drug: LiRIS 400 mg |
| LiRIS Placebo | Placebo comparator | LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days. If eligible, participants could participate in the Open Label Extension where all participants were treated with LiRIS 400 mg. Receives: Other: LiRIS Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Participant Reported Average Bladder Pain on a Numerical Rating Scale (NRS)
Participants rated their bladder pain over the previous 24 hours in an electronic diary using a horizontal line NRS by putting a mark on the line where: 0 (the far left of the line)=no pain to 10 (far right of the line)=worst pain imaginable. Bladder pain was averaged over a period of 3 days. A negative change from Baseline indicates improvement.
Measured: Baseline, Day 12
Secondary outcomes (8)
Change From Baseline in Total Daily Voids
Participants recorded number of daily voids (day-time and night-time daily voids) in a 3 day Voiding Frequency electronic diary. The total number of daily voids was averaged over a period of 3 full days. A negative change from Baseline indicates improvement.
Measured: Baseline, Day 27
Change From Baseline in Night-Time Daily Voids
Participants recorded number of night-time daily voids in a 3 day Voiding Frequency electronic diary. The total number of night-time daily voids was averaged over a period of 3 days. A negative change from Baseline indicates improvement.
Measured: Baseline, Day 27
Change From Baseline in Average Void Volume Per Micturition
Participants recorded the amount of each void in millimeters (mL) in an electronic diary. The total amount of void per micturition (each void) was averaged over a period of 24 days. A negative change from Baseline indicates improvement.
Measured: Baseline, Day 27
Change From Baseline in Post-Void Bladder Pain
Participants rated their bladder pain immediately completing voiding in an electronic diary using a horizontal line NRS by putting a mark on the line where: 0 (the far left of the line)=no pain to 10 (far right of the line)=worst pain imaginable. The average of the data from the first 5 voids prior to Baseline and the 3 days prior to Day 12 were averaged for analyses. A negative change from Baseline indicates improvement.
Measured: Baseline, Day 27
Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score
The ICSI is a participant reported questionnaire to rate their symptoms by answering 4 questions. Question (Q) 1 and 2 (urine urgency) using a 6-point scale where: 0=Not at All to 5=Almost Always. Q3 (night-time voids) using a 6-point scale where: 0=None to 5=5 or More Times. Q4 (pain and burning) using a 6-point scale where: 0=Not at All to 5=Usually. The total score is the sum of the individual scores for a total possible score of 0 (best) to 20 (worst). A negative change from Baseline indicates improvement.
Measured: Baseline, Day 27
Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score
The ICPI is a participant reported questionnaire to rate their problems in the following 4 areas: Frequent urination; Getting up at Night to Urinate: Urination with little warning; Burning pain and discomfort. Questions are answered on a 5-point scale where: 0=No Problem to 4=Big Problem. The total score is the sum of the individual scores for a total possible score of 0 (best) to 20 (worst). A negative change from Baseline indicates improvement.
Measured: Baseline, Day 27
Change From Baseline in Bladder Pain/Interstitial Cystitis Symptom Score (BPIC-SS)
The BPIC-SS is a participant reported questionnaire consisting of 8 items. Questions (Q) 1-5 (How often urination because of pain; Need to urinate after just urinating; How often urination to avoid worse pain; How often feeling of pressure in bladder; How often pain in bladder) answered on a 5-point scale where: 0=Never to 4=Always. Q 6-7 (Bothered by frequent Day-time urination; Bothered by Night-time urination) answered on a 5-point scale where: 0=Not At All to 4=A Great Deal. Q8 (pain) rated on a NRS by putting a mark on the line where: 0 (the far left of the line)=no pain to 10 (far right of the line)=worst pain imaginable. The Total Score is the sum of the individual questionnaire of all 8 items for a total possible score of 0 (best) to 38 (worst). A negative change indicates improvement.
Measured: Baseline, Day 27
Change From Baseline in Brief Pain Inventory (BPI)
The BPI is a 7-item participant completed questionnaire. The participant answered questions as to how pain interfered with: General Activity, Mood, Walking Ability, Normal work, Relations with other people, Sleep and Enjoyment of life. Questions were answered on an 11-point scale where: 0=Does not interfere to 10=Completely interferes. The total score is the average of the individual questionnaire items for a total possible score of 0 (best) to 10 (worst). A negative change from Baseline indicates improvement.
Measured: Baseline, Day 27
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionNov 2014
- Study completionDec 2014
Why it stopped: This study was terminated early due to company decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 31 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/Ontario Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01824303
- Sponsor's protocol ID
- TAR-100-202
- Status last verified
- Dec 2015
- First submitted
- 31 Mar 2013
- Last updated
- 26 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01824303
- Acronym / sponsor ID
- TAR-100-202
- Conditions
- Interstitial Cystitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was terminated early due to company decision.
- Enrolment
- 31 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Collaborators
- TARIS Biomedical, Inc.
- Study start
- Mar 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 4 Apr 2013 (estimated)
- Results
- Posted 26 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LiRIS 400 mg | Experimental | Drug: LiRIS 400 mgLiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days. If eligible, participants could participate in the Open Label Extension where all participants were treated with LiRIS 400 mg. |
| LiRIS Placebo | Placebo comparator | Other: LiRIS PlaceboLiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days. If eligible, participants could participate in the Open Label Extension where all participants were treated with LiRIS 400 mg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Women age 18 and over
- Diagnosed with Interstitial Cystitis as defined by protocol
- Able to report IC symptoms of bladder pain, voiding habits, as required by protocol, and record in diary
- Able to comply with visit schedule and diary completion at home
- Must have completed the blinded study prior to screening for the Open-label extension
Key exclusion criteria (4 listed)
- Pregnant or lactating women
- History or presence of any condition that would make it difficult to accurately evaluate bladder symptoms
- Bladder or urethral abnormality that would prevent safe insertion of investigational product
- Requiring medication not allowed per study protocol
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 400 mgLiRIS 400 mg contains lidocaine which is gradually released into the bladder over 14 days. | Drug | LiRIS 400 mg |
| LiRIS PlaceboLiRIS Placebo contains lactose, inactive substance. | Other | LiRIS Placebo |
Primary outcome
Change From Baseline in Participant Reported Average Bladder Pain on a Numerical Rating Scale (NRS)
Time frame: Baseline, Day 12
Participants rated their bladder pain over the previous 24 hours in an electronic diary using a horizontal line NRS by putting a mark on the line where: 0 (the far left of the line)=no pain to 10 (far right of the line)=worst pain imaginable. Bladder pain was averaged over a period of 3 days. A negative change from Baseline indicates improvement.
8 secondary outcomes
Change From Baseline in Total Daily Voids
Time frame: Baseline, Day 27
Change From Baseline in Night-Time Daily Voids
Time frame: Baseline, Day 27
Change From Baseline in Average Void Volume Per Micturition
Time frame: Baseline, Day 27
Change From Baseline in Post-Void Bladder Pain
Time frame: Baseline, Day 27
Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score
Time frame: Baseline, Day 27
Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score
Time frame: Baseline, Day 27
Change From Baseline in Bladder Pain/Interstitial Cystitis Symptom Score (BPIC-SS)
Time frame: Baseline, Day 27
Change From Baseline in Brief Pain Inventory (BPI)
Time frame: Baseline, Day 27
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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/Ontario Canada
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LiRIS 400 mg in people with Interstitial Cystitis, run by Allergan at 17 sites in 2 countries.
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 7 inclusion and 4 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: stopped early, as of the sponsor's last update on 26 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Participant Reported Average Bladder Pain on a Numerical Rating Scale (NRS) (time frame: Baseline, Day 12). 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 26 Jan 2016.