NCT01542567 (DIC-2011) is a Phase 3 clinical trial of Abitren in Bladder Cancer, sponsored by Carmel Medical Center.

Who is sponsoring NCT01542567?

NCT01542567 is sponsored by Carmel Medical Center.

What drugs are being tested in NCT01542567?

Interventions in NCT01542567: Abitren, Placebo.

What condition does NCT01542567 study?

NCT01542567 studies Bladder Cancer.

Is NCT01542567 still recruiting?

NCT01542567 is currently status unknown. Last updated 20 May 2012.

Last reviewed 2012-05-20 · How we verify

NCT01542567: DIC-2011

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Efficacy of Diclofenac Suppositories in Prevention of Immediate Side Effects of BCG Bladder Irrigations. A Double Blind Placebo Controlled Randomized Study

Status unknown Phase 3 Last updated 20 May 2012

What this trial tests

Phase 3 trial testing Abitren in Bladder Cancer in 100 participants. Status unknown.

Timeline

1 May 2012

Primary endpoint
1 May 2014

Quick facts

Lead sponsor	Carmel Medical Center
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	100
Start date	1 May 2012
Primary completion	1 May 2014

Drugs / interventions tested

Abitren — full drug profile →
Placebo

Conditions studied

Bladder Cancer — all drugs for Bladder Cancer →

Sponsor

Carmel Medical Center

Who can join

Adults 20 to 80, any sex, with Bladder Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Change in weekly COOP Questionnaire 1
Time frame: The questionnaires will be completed every week for the quality of life of the passing week. The complete time frame of all questionnaires will be 7 weeks
The bladder irrigations are delivered as an ambulatory treatment once a week. The questionnaires will be completed every week for the quality of life of the passing week.
Change in weekly COOP Questionnaire 2
Time frame: The questionnaires will be completed every week for the quality of life of the passing week. The complete time frame of all questionnaires will be 7 weeks
The bladder irrigations are delivered as an ambulatory treatment once a week. The questionnaires will be completed every week for the quality of life of the passing week.
Change in weekly COOP Questionnaire 3
Time frame: The questionnaires will be completed every week for the quality of life of the passing week. The complete time frame of all questionnaires will be 7 weeks
The bladder irrigations are delivered as an ambulatory treatment once a week. The questionnaires will be completed every week for the quality of life of the passing week.
Change in weekly Bladder symptoms Questionnaire
Time frame: The questionnaires will be completed every week for the bladder symptoms of the passing week. The complete time frame of all questionnaires will be 7 weeks
Bladder symptoms Questionnaire correlated to BCG treatment. The bladder irrigations are delivered as an ambulatory treatment once a week. The questionnaires will be completed every week for the bladder symptoms of the passing week.
Change in weekly time schedule questionnaire
Time frame: every week for 6 weeks
A questionnaire designed to measure the time in minutes that the patient was able to retain the BCG in the bladder.This questionnaire will be completed every week for the same day of weekly irrigation.

Sponsor's own description

This study is designed to test the effectiveness of diclofenac suppositories in the prophylaxis of side effects caused by BCG bladder irrigations in bladder cancer patients.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Bladder Cancer

Currently open trials in the same condition.

NCT07419295 — A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) to Treat Urothelial Cancer (MK-2870-031) · Phase 3 · recruiting
NCT07322263 — Intravesical GEM/DOCE for HR BCG-Unresponsive NMIBC · Phase 2 · recruiting
NCT07420517 — Dutasteride in Patients With Low Grade Non-muscle Invasive Bladder Cancer · Phase 2 · recruiting
NCT07475403 — Urinary Tumor DNA-Guided Systemic Immunotherapy for Unresectable Very-High-Risk Non-Muscle-Invasive Bladder Cancer · Phase 2 · recruiting
NCT07277413 — A Study of IDE892 as Monotherapy and Combination in MTAP-deleted Advanced Solid Tumors · Phase 1 · recruiting

Other Carmel Medical Center trials

Trials by the same sponsor.

NCT06604455 — Impact of Acupuncture and Integrative Medicine on Patients Quality-of-life During National Emergency and Wartime · NA · recruiting
NCT06612749 — Assessing the Impact of Integrative Medicine on Anxiety and Wellbeing of Healthcare Providers Exposed to Terror or War · NA · recruiting
NCT06598020 — Evaluating the Impact of an Integrative Oncology Training Program for Healthcare Providers · NA · active not recruiting
NCT06590766 — Impact of Acupuncture and Manual Therapies on Patients' Quality-of-life in a Hospital-to-community Continuum · NA · recruiting
NCT06167057 — POST URS Chemotherapy Instillation · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01542567 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Carmel Medical Center
Last refreshed: 20 May 2012

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01542567.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing