Intravesical Liposomes for Ulcerative Cystitis

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Kenneth Peters, MD, William Beaumont Hospitals

ClinicalTrials.gov Identifier:

NCT01083979

First received: March 8, 2010

Last updated: November 15, 2012

Last verified: November 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

March 8, 2010

Last Updated Date

November 15, 2012

Start Date ^ICMJE

August 2010

Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in symptom severity [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]

The primary objective is to determine the impact of 4 weekly bladder instillations of liposomes on symptoms in one patient with ulcerative IC. The primary endpoint will be changes in symptom severity from baseline to the end of weeks 4 and 8 as measured by the O'Leary-Sant IC Symptom and Problem Indices (ICSI-PI) questionnaire.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01083979 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Safety and Tolerability [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: Yes ]

The secondary objective is to determine the safety and tolerability of liposomes instilled into the bladder as a compassionate use treatment in one patient with ulcerative IC. Secondary endpoints will include:

Assessment of adverse events; changes in urinary frequency, urgency, and pelvic pain as recorded on voiding diaries at baseline, and at 4 and 8 weeks; cystoscopic changes in bladder inflammation/ulcers.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Intravesical Liposomes for Ulcerative Cystitis

Official Title ^ICMJE

Intravesical Liposomes for Ulcerative Cystitis

Brief Summary

The objective is to instill liposomes reconstituted with sterile water into the bladder as a compassionate use treatment in one patient with ulcerative interstitial cystitis (IC).

Detailed Description

A physician sponsored IND has been acquired from the FDA for compassionate use of this non-approved treatment in one patient from Dr. Peters' private practice. Since this treatment has not been used previously in the US, we propose to evaluate the safety and efficacy of the treatment in this one patient by comparing pre and post treatment symptom changes.

Prior to treatment (visit 1) baseline measures will be assessed: vital signs,pelvic/bladder pain on a visual analog scale (VAS; "0" being none and "10" being severe), concomitant medications, Serum pregnancy test and Antiphospholipid Antibody Panel, Urine cytology, urinalysis (dipstick), and culture.

At visits 2-5 (4 treatment visits) questionnaires will be completed and vital signs, pain VAS, post void residual (measured by bladder scan or catheter), unanticipated events, and voiding history (voiding diary) will also be assessed. Additionally, cystoscopy will be done prior to the first treatment to view the bladder lining. At each treatment visit, the patients will have a solution of liposomes instilled in the bladder with a catheter, retained for 30 minutes, and be carefully monitored for at least 1 hour after the liposomes are drained.

After treatment, visits 6 and 7 (follow up) will include vital signs with VAS pain assessment, PVR, urinalysis (dipstick), unanticipated events assessment, questionnaire completion and review of voiding diary. Visit 8 (study exit) will include the same parameters measured at follow up visits 6 and 7 with the addition of cystoscopy and Antiphospholipid Antibody Panel testing.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Interstitial Cystitis

Intervention ^ICMJE

Drug: Liposomes

Intravesical instillation

Other Name: Bladder instillation

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2010

Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Ulcerative IC for at least 6 months documented,
Negative urine cytology,
Able to independently complete self administered questionnaires and voiding diaries.

Exclusion Criteria:

Pregnant or lactating,
History of bleeding diathesis,
On anticoagulant therapy,
Active peptic ulcer disease,
Obvious neurological impairment,
Known allergy to liposomes.

Gender

Both

Ages

20 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01083979

Other Study ID Numbers ^ICMJE

2010-021

Has Data Monitoring Committee

Responsible Party

Kenneth Peters, MD, William Beaumont Hospitals

Study Sponsor ^ICMJE

Kenneth Peters, MD

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Kenneth M Peters, MD

William Beaumont Hospitals

Information Provided By

William Beaumont Hospitals

Verification Date

November 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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