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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT01295814
Date of registration: 14/02/2011
Prospective Registration: Yes
Primary sponsor: ICStudy, LLC
Public title: Efficacy Study of Adalimumab to Treat Interstitial Cystitis
Scientific title: An Investigator Initiated, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of Humira® (Adalimumab) For The Treatment of Interstitial Cystitis(IC)
Date of first enrolment: March 2011
Target sample size: 43
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01295814
Study type:  Interventional
Study design:   
Phase:  Phase 3
Countries of recruitment
United States
Contacts
Name:     Philip C Bosch, MD
Address: 
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion criteria

Inclusion Criteria:

- Males or females =18 and = 65 years of age previously diagnosed with Interstitial
Cystitis

- Currently have symptoms of urinary urgency, frequency or pain for more than 6 months

- Urinating at least 7 times a day or having some urgency or pain (measured on linear
analog scales)

- Must be post-menopausal or surgically sterile or willing to use an adequate form of
birth control

- Not pregnant or lactating

- Capable of voiding independently

- Willing to provide informed consent to participate

Exclusion Criteria:

- Have symptoms that are presently relieved on other medications for interstitial
cystitis

- Have absence of nocturia

- Have symptoms that are relieved by antimicrobials or antibiotics.

- Have a body mass index (BMI) of >39 kg/m2

- Have uncontrolled hypertension

- Have Type I or type 2 diabetes

- Have active Hepatitis B, Hepatitis C, or Human Immunodeficiency Virus (HIV) infection,
or who are known carriers (Hepatitis B) at Screening

- Have a positive tuberculosis test at screening

- Have had a urinary tract infection for 6 weeks

- Have had bacterial cystitis in previous 3 months

- Have had previous exposure to Humira® (adalimumab)

- Have taken investigational medication within 30 days of screening

- Have any other condition/disease which, in the opinion of the investigator, could
compromise subject safety or confound the interpretation of study results

- Are unable or unwilling to comply with protocol requirements



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All
Health Condition(s) or Problem(s) studied
Interstitial Cystitis
Intervention(s)
Drug: Adalimumab
Other: inactive drug
Primary Outcome(s)
O'Leary-Santa Interstitial Cystitis Symptom Index and Problem Index (OSPI) Score [Time Frame: Baseline/12 Weeks]
Secondary Outcome(s)
Interstitial Cystitis Symptom Index (ICSI) [Time Frame: Baseline/ 12 weeks]
Pelvic Pain Urgency/Frequency (PUF) Score [Time Frame: Baseline12 Weeks]
Interstitial Cystitis Problem Index (ICPI) [Time Frame: Baseline/12 Weeks]
Global Response Assessment (GRA) [Time Frame: Measured at12 Weeks]
Secondary ID(s)
IMM 10-0061
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Abbott
Ethics review
Results
Results available: Yes
Date Posted: 16/07/2015
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT01295814
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