NCT00365508 is a Phase 4 clinical trial of nicotine lozenge in Bladder Cancer, sponsored by Fox Chase Cancer Center.

Who is sponsoring NCT00365508?

NCT00365508 is sponsored by Fox Chase Cancer Center.

What drugs are being tested in NCT00365508?

Interventions in NCT00365508: nicotine lozenge, nicotine patch.

What condition does NCT00365508 study?

NCT00365508 studies Bladder Cancer, Cervical Cancer, Esophageal Cancer, Gastric Cancer, Head and Neck Cancer, Kidney Cancer, Leukemia, Liver Cancer, Lung Cancer, Pancreatic Cancer, Tobacco Use Disorder.

Is NCT00365508 still recruiting?

NCT00365508 is currently completed. Last updated 1 March 2016.

Are results published for NCT00365508?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2016-03-01 · How we verify

NCT00365508

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

Comparing the Lozenge to the Patch for Smoking Cessation

Completed Phase 4 Results posted Last updated 1 March 2016

What this trial tests

Phase 4 trial testing nicotine lozenge in Bladder Cancer in 642 participants. Completed in 1 August 2009.

Timeline

1 February 2006

Primary endpoint
1 August 2009

1 August 2009

Quick facts

Lead sponsor	Fox Chase Cancer Center
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	none
Primary purpose	treatment
Enrollment	642
Start date	1 February 2006
Primary completion	1 August 2009
Estimated completion	1 August 2009
Sites	10 locations across United States

Drugs / interventions tested

nicotine lozenge — full drug profile →
nicotine patch (nicotine-patch) — full drug profile →

Conditions studied

Bladder Cancer — all drugs for Bladder Cancer →
Cervical Cancer — all drugs for Cervical Cancer →
Esophageal Cancer — all drugs for Esophageal Cancer →
Gastric Cancer — all drugs for Gastric Cancer →

Sponsor

Fox Chase Cancer Center — full company profile →

Who can join

18 and older, any sex, with Bladder Cancer or Cervical 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.

24-hour Point Prevalence Abstinence at the 6-month Follow up
Time frame: 6-months

Sponsor's own description

RATIONALE: Stop-smoking plans, including counseling and nicotine replacement therapy, may help smokers quit smoking. It is not yet known whether counseling and the nicotine lozenge is more effective than counseling and the nicotine patch in helping adult smokers quit smoking. PURPOSE: This randomized phase III trial is studying counseling and the nicotine lozenge to see how well they work compared to counseling and the nicotine patch in helping smokers quit smoking.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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 Fox Chase Cancer Center trials

Trials by the same sponsor.

NCT07455032 — Neoadjuvant CADI-05 in Combination With Pembrolizumab for Surgically Resectable Locally Advanced Head and Neck Squamous · Phase 1 · recruiting
NCT07221942 — Pembrolizumab Maintenance After Enfortumab Vedotin (EV)/Pembro Induction in Front-Line Metastatic Urothelial Carcinoma · Phase 2 · recruiting
NCT07221058 — Adaptive Radiation Boost for Rectal Cancer · Phase 1 · recruiting
NCT07167446 — Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy · EARLY_PHASE1 · recruiting
NCT07219303 — Adaptive Radiation Therapy for Men With Intermediate- or High-Risk Prostate Cancer · 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 NCT00365508 (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 Fox Chase Cancer Center
Last refreshed: 1 March 2016

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/NCT00365508.

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