Trial record 6 of 39 for:
Open Studies | "Cystitis"
Efficacy of Intravesical LP08 in Patients With Interstitial Cystitis/Painful Bladder Syndrome
This study is not yet open for participant recruitment.
Verified May 2013 by Lipella Pharmaceuticals, Inc.
Sponsor:
Lipella Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Lipella Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01393223
First received: July 7, 2011
Last updated: May 18, 2013
Last verified: May 2013
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Purpose
The purpose of this study is to assess the safety and tolerability of intravesical LP08. Hypothesis: Adverse event profiles in the LP08 treated group will not be significantly different from the placebo group.
| Condition | Intervention | Phase |
|---|---|---|
|
Interstitial Cystitis Painful Bladder Syndrome |
Drug: LP-08 Drug: Inactive Saline Placebo |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Efficacy of Intravesical LP08 in Patients With Interstitial Cystitis/Painful Bladder Syndrome |
Resource links provided by NLM:
Further study details as provided by Lipella Pharmaceuticals, Inc.:
Primary Outcome Measures:
- Safety [ Time Frame: Up to 31 weeks following treatment ] [ Designated as safety issue: Yes ]The number/severity of adverse events throughout the study
Secondary Outcome Measures:
- Efficacy Voids Per Day (VPD) [ Time Frame: 2, 4, 8, 16, 24 weeks following treatment ] [ Designated as safety issue: No ]The change in voids per day (urinary frequency) as measured on a 3 day voiding diary
- Efficacy Global Response Assessment (GRA) [ Time Frame: 4, 8, 16, 24 weeks following treatment ] [ Designated as safety issue: No ]Reporting a "moderate" or "marked" improvement on the GRA
- Efficacy Symptom [ Time Frame: 2, 4, 8, 16, 24 weeks following treatment ] [ Designated as safety issue: No ]The change in the symptoms and problems of interstitial cystitis from the baseline as measured by the O'Leary-Sant Interstitial Cystitis Symptom Index
- Efficacy Visual Analog Scale (VAS) [ Time Frame: 2, 4, 8, 16, 24 weeks following treatment ] [ Designated as safety issue: No ]The change in pain as recorded on the VAS
- Efficacy Diary [ Time Frame: 2, 4, 8, 16, 24 weeks following treatment ] [ Designated as safety issue: No ]The change from baseline in average voided volume, urgency and nocturia episodes per day as measured on a 3 day voiding diary
| Estimated Enrollment: | 30 |
| Study Start Date: | December 2013 |
| Estimated Study Completion Date: | February 2015 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Liposomes
Experimental
|
Drug: LP-08
Intravesical instillation
|
|
Placebo Comparator: Saline
Saline
|
Drug: Inactive Saline Placebo
Intravesical instillation
|
Detailed Description:
A double blinded, randomized, paralleled, placebo-controlled trial of 30 patients receiving either intravesical LP08 instillations or placebo twice weekly for four weeks. Systemic safety will be monitored by clinical and hemodynamic examination, electrocardiography (ECG), measuring vital signs (temperature, blood pressure, heart rate and respiration) and performing standard laboratory studies. Any local adverse effect (hematuria, micturition pain, urinary tract infection, urinary retention) that may occur after intravesical administration will be recorded and managed.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age from 18 to 70 years inclusive;
- Have IC that meets the disease diagnostic criteria;
- Provide signed informed consent
Exclusion Criteria:
- Currently pregnant or breastfeeding
- Intravesical therapy or bladder hydrodistention within the previous 60 days
- Has taken pentosan polysulfate sodium (Elmiron) within the previous 4 weeks
- Use of fentanyl patches, morphine sulfate, methadone, oxycodone, Opana, percocet or B&O
- Supprettes within the previous 30 days (allowable narcotics include vicodin, -Tylenol with codeine, darvocet n-100, tramadol)
- Previous augmentation cystoplasty, cystectomy, neurectomy (i.e., hypogastric nerve plexus ablation) or active implanted peripheral nerve stimulator which has affected bladder function.
- Evidence of renal impairment (creatinine > 2 times the upper limit of normal at Visit 1), hepatic impairment (AST or ALT >3 times the upper limit of normal at Visit 1), -clinically significant cardiovascular, respiratory, or psychiatric diseases
- 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
- Treatment with a medical that has not received regulatory approval within the previous 30 days.
- Investigators, study staff and their immediate families. Immediate family is defined as current spouse, parent, natural or legally adopted child (including a stepchild living in the investigator's household), grandparent, or grandchild.
- Previously completed or withdrawn from this study
- Urinary tract or prostatic infection in the past 3 months before study entry
- Active genital herpes or vaginitis
- Urethral diverticulum
- Pelvic malignancy within the past 5 years
- History of cyclophosphamide or chemical cystitis, or tuberculosis or radiation cystitis
- History of bladder tumors (benign or malignant)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01393223
Contacts
| Contact: Jonathan Kafuman, PhD | 412-894-1853 | jhk@lipella.com |
| Contact: Michele Anthony, BS | 412-894-1853 | michele.anthony@lipella.com |
Locations
| United States, Pennsylvania | |
| Pending | Not yet recruiting |
| Pittsburgh, Pennsylvania, United States | |
| Contact: Jonathan Kaufman, PhD 412-894-1853 jhk@lipella.com | |
| Contact: Michele Anthony, BS 412-894-1853 michele.anthony@lipella.com | |
Sponsors and Collaborators
Lipella Pharmaceuticals, Inc.
More Information
No publications provided
| Responsible Party: | Lipella Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT01393223 History of Changes |
| Other Study ID Numbers: | 30p Lipella LP-08 IC |
| Study First Received: | July 7, 2011 |
| Last Updated: | May 18, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Lipella Pharmaceuticals, Inc.:
|
Interstitial Cystitis Painful Bladder Syndrome Liposome |
Additional relevant MeSH terms:
|
Cystitis Pain Cystitis, Interstitial Urinary Bladder Diseases |
Urologic Diseases Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013