Interstitial Cystitis

ICOS Corporation

Status and phase

Completed

Phase 2

Conditions

Interstitial Cystitis

Treatments

Procedure: H&P; ECG; Blood tests; voiding diary; Cystoscopy

Study type

Interventional

Funder types

Industry

Identifiers

NCT00056251

JIC01

Details and patient eligibility

About

Patients with interstitial cystitis who meet eligibility requirements will be randomized to one of four treatment arms (3 RTX, Placebo). Study drug is administered as a single instillation within the urinary bladder. Study duration is 12 weeks.

Full description

RATIONALE:

Topical resiniferatoxin (RTX) administrated to the bladder may be effective in decreasing the symptoms associated with interstitial cystitis through its action on pain sensing neurons.

PURPOSE:

Randomized, double-blind, placebo-controlled, Phase 2 trial to determine the safety and efficacy of RTX in patients with interstitial cystitis.

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

≥ 18 years of age.
Have IC that meets disease diagnostic criteria as defined by a history of the following:
Cystoscopy/hydrodistension with a diagnosis of IC confirmed by findings of Hunner's ulcer or glomerulation
Symptoms of bladder pain and urinary urgency for at least 6 months
Urinary frequency while awake at least 8 times a day while awake
Nocturia at least twice a night
Symptoms not significantly relieved by antimicrobial agents, anticholinergic drugs, or antispasmodics
Have IC that in the judgment of the investigator has been stable in the previous 30 days
Have IC-related pain despite current therapy, defined as a score of 4 or greater [(on a scale from 0 (none) to 9 (severe)] on average over the past month and confirmed by the voiding diary collected at Visit 2
Have at least one voided volume ≥ 75 cc in a 24 hour period, confirmed by the voiding diary collected at Visit 2
Patients of childbearing potential must agree to use an acceptable form of contraception (oral contraceptives, intrauterine device or double barrier methods) from Visit 1 through Visit 6
Provide signed informed consent

Exclusion criteria

Currently pregnant or breastfeeding
Presence of ulcers on the pre-treatment cystoscopy
Intravesical therapy or bladder hydrodistention within the previous 60 days
Initiation of pentosan polysulfate sodium (Elmiron®) within the previous 16 weeks
Use of fentanyl patches, morphine sulfate, methadone or B&O supprettes within the previous 30 days.
Previous augmentation cystoplasty, cystectomy or cystolysis, neurectomy (i.e., hypogastric nerve plexus ablation) or implanted peripheral nerve stimulator which has affected bladder function
History of ureteral reflux. Patients with a history of childhood urinary tract infections, recurrent urinary tract infections as an adult (defined as >3 culture documented episodes within the previous 12 months), or pyelonephritis at any time must have a cystourethogram to rule out ureteral reflux.
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 drug or medical device 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 within the past 3 months before study entry
Active genital herpes or vaginitis
Urethral diverticulum
Uterine, cervical, vaginal, or urethral cancer within the past 5 years before study entry
History of cyclophosphamide or chemical cystitis, urinary tuberculosis or radiation cystitis
History of bladder tumors (benign or malignant)