Interstitial CystitisPhase 2NCT01393223
Evaluation of Intravesical LP08 in Patients With Interstitial Cystitis/Painful Bladder Syndrome
A Phase 2 study testing LP-08 80mg, Normal saline and LP-08 20mg in people with Interstitial Cystitis, run by Lipella Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to assess the safety and tolerability of two doses of LP08 compared to placebo. Hypothesis: Safety of the LP-08 therapy will not be significantly different from the placebo group. Secondary Efficacy Endpoints: A matched-pair data analysis design will be employed, i.e. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Interstitial Cystitis
- What is being tested?
- LP-08 80mg, Normal saline and LP-08 20mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2015to 14 Jun 2018
- Phase
- Phase 2
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A patient is deemed suitable for inclusion in the study if the patient meets the following criteria:
- Male or female at least 18 years of age
- IC/BPS diagnosed by a health care provider based the following criteria:
- Complaint of suprapubic pain related to bladder filling, accompanied by other symptoms such as increased daytime and night time frequency, in the absence of proven urinary infection or other obvious pathology Have had IC/BPS symptoms for at least six months Score of ≥ 12 on the ICSI/PI at baseline Urinary frequency > 10 times a day by self-report and confirmed on baseline three-day voiding diary Have IC/BPS that in the judgment of the investigator has been stable in the previous 30 days IC/BPS-related pain defined as a score of > 3 cm and < 9 cm on the pain VAS where 0 is no pain and 10 is maximum pain
- Have had inadequate clinical responses with conservative treatments, which may include one or more of the following: 1) timed voiding and behavioral modification therapy, 2) dietary restrictions, 3) stress reduction and/or 5) oral therapy with any of the following medications:
- Antidepressants Antihistamines Antimuscarinic and anticholinergic agents Alpha adrenergic blockers Analgesics Pentosan polysulfate
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- Women of childbearing potential: have a negative urine pregnancy test at screening, and must agree to use an acceptable from of contraception (oral contraceptives, intrauterine or double barrier methods), as agreed to by the investigator, during the study period
- Provide signed informed consent
- Subject agrees to be available for the follow-up evaluations as required by the protocol
Who cannot join
- Patients are excluded from enrollment in the study if any of the following are true:
- Currently pregnant or breastfeeding, or plan to become pregnant during the course of the study
- Have received investigational products or devices within 30 days prior to screening visit
- Have received intravesical therapy or bladder hydrodistention within 30 days prior to screening visit. Intravesical instillations may include liquid or drug delivery devices, pentosan polysulfate sodium, lidocaine, steroid, heparin, chondroitin and any combination or additional formulation.
- Have participated in IC/BPS research trial within 90 days prior to screening visit or has not returned to baseline if participated in IC/BPS research trial greater than 90 days prior to screening visit
- Have received any of the following medication within 30 days of screening visit, unless such medications have been administered at a stable dose during this month and are expected to remain at a stable dose throughout the study:
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- Antidepressants Antihistamines (use of antihistamines as needed for allergies is allowed) Anticonvulsants Antimuscarinic and anticholinergic agents Alpha adrenergic blockers Pentosan polysulfate sodium Oral chondroitin
- Have indicated use of > 70 mg of morphine equivalents of opioids per week to control their IC/BPS pain within 30 days prior to screening, or are expected to require this level of IC/BPS pain control during the study period
- Previous augmentation cystoplasty, cystectomy, neurectomy (i.e., hypogastric nerve plexus ablation). Bladder botulinum toxin injections within nine months prior to screening.
- Sacral and/or pudendal nerve neuromodulation device (Interstim) within the last 6 months. Subjects would not be excluded if they had Interstim greater than 6 months ago and is on a stable setting within the past 90 days
- Percutaneous Tibial Nerve Stimulation (PTNS) treatment within the past 90 days
- Evidence of renal impairment (creatinine > two times the upper limit of normal at Visit 1), hepatic impairment (AST or ALT > three times the upper limit of normal at Visit 1), clinically significant cardiovascular, respiratory, or psychiatric diseases per investigator's judgment
- Post-void residual (PVR) urine volume of > 150 mL at screening
- Any condition that in the judgment of the investigator would interfere with the patient's ability to provide informed consent, comply with study instructions, place the patient at increased risk, or which might confound the interpretation of the study results
- Previously received intravesical liposomes
- Urinary tract or prostatic infection in the past 90 days before study entry
- Active genital herpes or vaginitis
- Urethral diverticulum
- Pelvic malignancy within the past five years
- History of cyclophosphamide or chemical cystitis, or tuberculosis or pelvic radiation
- History of bladder or prostate tumors (benign or malignant)
- Uncontrolled diabetes
- Has any condition that would preclude treatment due to contraindications and/or warnings in the product labeling
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Double-Blind, Randomized, Dose-Ranging, Placebo Controlled Trial Comparing the Safety, Tolerability and Efficacy of LP-08 With Placebo in Subjects With Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)
The purpose of this study is to assess the safety and tolerability of two doses of LP08 compared to placebo. Hypothesis: Safety of the LP-08 therapy will not be significantly different from the placebo group. Secondary Efficacy Endpoints: A matched-pair data analysis design will be employed, i.e. the measured outcomes will be subjects' improvements in quantitative and qualitative measures of the disease condition being assessed prior to and after LP-08 instillations at four and eight weeks follow-up visits
Read the detailed description
This is a single-center, dose-ranging, placebo-controlled, double-blind, randomized study including male and female subjects with interstitial cystitis/bladder pain syndrome (IC/BPS) as determined by a physician using the current diagnostic criteria for IC/BPS. A total of 36 subjects will be enrolled at up to five (5) study sites in the U.S. Enrollment is expected to be completed within one year of initiating the study. The study is comprised of two parts. The first part of the study is a dose-ranging, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability and efficacy of LP-08 at 20 mg and 80 mg doses as compared with placebo. The second part of the study is an Open Label Extension study of the safety, tolerability and efficacy of LP-08 80 mg. Subjects randomized to the placebo control group must have completed the randomized portion study, including the eight week follow-up period, to be eligible for the Open Label Extension.
- Conditions
- Interstitial Cystitis
- Being tested
- LP-08 80mg, Normal saline, LP-08 20mg
- Keywords
- Interstitial Cystitis, Painful Bladder Syndrome, Bladder Pain Syndrome, Liposome, LP-08
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LP-08 80mgDrug
Intravesical instillation of 80mg LP08
Normal salineDrug
Intravesical instillation of normal saline
LP-08 20mgDrug
Intravesical instillation of 20mg LP08
| Study group | Role | What they receive |
|---|---|---|
| LP-08 80mg | Active comparator | 4 weekly intravesical administration of LP-08 80mg Receives: Drug: LP-08 80mg |
| LP-08 20mg | Active comparator | 4 weekly intravesical administration of LP-08 20mg Receives: Drug: LP-08 20mg |
| Normal Saline | Placebo comparator | Four weekly normal saline intravesical administration Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Intravesical LP08: number/severity of adverse events
The number/severity of adverse events throughout the study
Measured: Up to 31 weeks following treatment
Secondary outcomes (5)
Efficacy Voids Per Day (VPD)
The change in voids per day (urinary frequency) as measured on a 3 day voiding diary
Measured: 2, 4, 8, 16, 24 weeks following treatment
Efficacy Global Response Assessment (GRA)
Reporting a "moderate" or "marked" improvement on the GRA
Measured: 4, 8, 16, 24 weeks following treatment
Efficacy Symptom
The change in the symptoms and problems of interstitial cystitis from the baseline as measured by the O'Leary-Sant Interstitial Cystitis Symptom Index
Measured: 2, 4, 8, 16, 24 weeks following treatment
Efficacy Visual Analog Scale (VAS)
The change in pain as recorded on the VAS
Measured: 2, 4, 8, 16, 24 weeks following treatment
Efficacy Diary
The change from baseline in average voided volume, urgency and nocturia episodes per day as measured on a 3 day voiding diary
Measured: 2, 4, 8, 16, 24 weeks following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2011 (estimated)
- Study start21 Jul 2015
- Primary completion14 Jun 2018
- Study completion14 Jun 2018
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lipella Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Corewell Health East
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01393223
- Sponsor's protocol ID
- PhaseII LP-08 IC/BPS
- Status last verified
- Oct 2018
- First submitted
- 7 Jul 2011
- Last updated
- 1 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Double-Blind, Randomized, Dose-Ranging, Placebo Controlled Trial Comparing the Safety, Tolerability and Efficacy of LP-08 With Placebo in Subjects With Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)
- ClinicalTrials.gov ID
- NCT01393223
- Acronym / sponsor ID
- PhaseII LP-08 IC/BPS
- Conditions
- Interstitial Cystitis
- Keywords
- Interstitial Cystitis, Painful Bladder Syndrome, Bladder Pain Syndrome, Liposome, LP-08
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Lipella Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Corewell Health East
- Study start
- 21 Jul 2015 (actual)
- Primary completion
- 14 Jun 2018 (actual)
- Study completion
- 14 Jun 2018 (actual)
- First posted
- 13 Jul 2011 (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 to assess the safety and tolerability of two doses of LP08 compared to placebo. Hypothesis: Safety of the LP-08 therapy will not be significantly different from the placebo group. Secondary Efficacy Endpoints: A matched-pair data analysis design will be employed, i.e. the measured outcomes will be subjects' improvements in quantitative and qualitative measures of the disease condition being assessed prior to and after LP-08 instillations at four and eight weeks follow-up visits
Detailed description
This is a single-center, dose-ranging, placebo-controlled, double-blind, randomized study including male and female subjects with interstitial cystitis/bladder pain syndrome (IC/BPS) as determined by a physician using the current diagnostic criteria for IC/BPS. A total of 36 subjects will be enrolled at up to five (5) study sites in the U.S. Enrollment is expected to be completed within one year of initiating the study. The study is comprised of two parts. The first part of the study is a dose-ranging, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability and efficacy of LP-08 at 20 mg and 80 mg doses as compared with placebo. The second part of the study is an Open Label Extension study of the safety, tolerability and efficacy of LP-08 80 mg. Subjects randomized to the placebo control group must have completed the randomized portion study, including the eight week follow-up period, to be eligible for the Open Label Extension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LP-08 80mg | Active comparator | Drug: LP-08 80mg4 weekly intravesical administration of LP-08 80mg |
| LP-08 20mg | Active comparator | Drug: LP-08 20mg4 weekly intravesical administration of LP-08 20mg |
| Normal Saline | Placebo comparator | Drug: Normal salineFour weekly normal saline intravesical administration |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- A patient is deemed suitable for inclusion in the study if the patient meets the following criteria:
- Male or female at least 18 years of age
- IC/BPS diagnosed by a health care provider based the following criteria:
- Complaint of suprapubic pain related to bladder filling, accompanied by other symptoms such as increased daytime and night time frequency, in the absence of proven urinary infection or other obvious pathology Have had IC/BPS symptoms for at least six months Score of ≥ 12 on the ICSI/PI at baseline Urinary frequency > 10 times a day by self-report and confirmed on baseline three-day voiding diary Have IC/BPS that in the judgment of the investigator has been stable in the previous 30 days IC/BPS-related pain defined as a score of > 3 cm and < 9 cm on the pain VAS where 0 is no pain and 10 is maximum pain
- Have had inadequate clinical responses with conservative treatments, which may include one or more of the following: 1) timed voiding and behavioral modification therapy, 2) dietary restrictions, 3) stress reduction and/or 5) oral therapy with any of the following medications:
Key exclusion criteria (23 listed)
- Currently pregnant or breastfeeding, or plan to become pregnant during the course of the study
- Have received investigational products or devices within 30 days prior to screening visit
- Have received intravesical therapy or bladder hydrodistention within 30 days prior to screening visit. Intravesical instillations may include liquid or drug delivery devices, pentosan polysulfate sodium, lidocaine, steroid, heparin, chondroitin and any combination or additional formulation.
- Have participated in IC/BPS research trial within 90 days prior to screening visit or has not returned to baseline if participated in IC/BPS research trial greater than 90 days prior to screening visit
- Have received any of the following medication within 30 days of screening visit, unless such medications have been administered at a stable dose during this month and are expected to remain at a stable dose throughout the study:
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 |
|---|---|---|
| LP-08 80mgIntravesical instillation of 80mg LP08 | Drug | LP-08 80mg |
| Normal salineIntravesical instillation of normal saline | Drug | Normal Saline |
| LP-08 20mgIntravesical instillation of 20mg LP08 | Drug | LP-08 20mg |
Primary outcome
Safety of Intravesical LP08: number/severity of adverse events
Time frame: Up to 31 weeks following treatment
The number/severity of adverse events throughout the study
5 secondary outcomes
Efficacy Voids Per Day (VPD)
Time frame: 2, 4, 8, 16, 24 weeks following treatment
Efficacy Global Response Assessment (GRA)
Time frame: 4, 8, 16, 24 weeks following treatment
Efficacy Symptom
Time frame: 2, 4, 8, 16, 24 weeks following treatment
Efficacy Visual Analog Scale (VAS)
Time frame: 2, 4, 8, 16, 24 weeks following treatment
Efficacy Diary
Time frame: 2, 4, 8, 16, 24 weeks following treatment
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 1 Nov 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LP-08 80mg, Normal saline and LP-08 20mg in people with Interstitial Cystitis, run by Lipella Pharmaceuticals, Inc. at 1 site in United States.
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 9 inclusion and 23 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 1 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
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?
Safety of Intravesical LP08: number/severity of adverse events (time frame: Up to 31 weeks following treatment). 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 1 Nov 2018.