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: July 31, 2013
Last verified: July 2013

March 8, 2010
July 31, 2013
August 2010
October 2010   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01083979 on ClinicalTrials.gov Archive Site
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.

Same as current
Not Provided
Not Provided
 
Intravesical Liposomes for Ulcerative Cystitis
Intravesical Liposomes for Ulcerative Cystitis

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).

A physician sponsored Investigation New Drug (IN) 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, post void residual (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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Interstitial Cystitis
Drug: Liposomes
Intravesical instillation
Other Name: Bladder instillation
Experimental: Liposomes
Intravesical instillation of Liposomes in sterile water totally 40 cc at four weekly treatments.
Intervention: Drug: Liposomes
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1
October 2010
October 2010   (final data collection date for primary outcome measure)

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.
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01083979
2010-021
No
Kenneth Peters, MD, William Beaumont Hospitals
Kenneth Peters, MD
Not Provided
Principal Investigator: Kenneth M Peters, MD William Beaumont Hospitals
William Beaumont Hospitals
July 2013

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