Who is sponsoring NCT00385515?

NCT00385515 is sponsored by Mucosal Therapeutics.

What drugs are being tested in NCT00385515?

Interventions in NCT00385515: SNX-1012 (meclocycline sulfosalicylate), placebo.

What condition does NCT00385515 study?

NCT00385515 studies Stomatitis, Oral Mucositis.

Is NCT00385515 still recruiting?

NCT00385515 is currently completed. Last updated 8 April 2009.

Are results published for NCT00385515?

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

Last reviewed 2009-04-08 · How we verify

NCT00385515

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

A Phase 2, Randomized, Double-Masked, Placebo-Controlled Study to Evaluate the Efficacy of SNX-1012 in Reducing the Duration and Severity of Ulcerative Oral Mucositis in Patients Receiving Cytotoxic Chemotherapy for Breast or Lung Cancer

Completed Phase 2 Results posted Last updated 8 April 2009

What this trial tests

Phase 2 trial testing SNX-1012 (meclocycline sulfosalicylate) in Stomatitis in 81 participants. Completed in 1 July 2008.

Timeline

1 June 2006

Primary endpoint
1 May 2008

1 July 2008

Quick facts

Lead sponsor	Mucosal Therapeutics
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	81
Start date	1 June 2006
Primary completion	1 May 2008
Estimated completion	1 July 2008
Sites	27 locations across United States, India

Drugs / interventions tested

SNX-1012 (meclocycline sulfosalicylate) — full drug profile →
placebo

Conditions studied

Stomatitis — all drugs for Stomatitis →
Oral Mucositis — all drugs for Oral Mucositis →

Sponsor

Mucosal Therapeutics — full company profile →

Who can join

18 and older, any sex, with Stomatitis or Oral Mucositis. 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.

Duration of Ulcerative Oral Mucositis
Time frame: At least 10 consecutive days beginning on Day 1 of a chemotherapy cycle
All randomized subjects were directly observed by trained evaluators for at least 10 consecutive days during the chemotherapy cycle to document the duration for those that developed recurrent ulcerative oral mucositis

Sponsor's own description

Oral mucositis (OM) is a common and debilitating toxicity induced by many chemotherapy (CT) regimens and by radiation to the head and neck. The purpose of this study is to determine the effectiveness of SNX-1012 in decreasing the duration of Grade 2, 3, or 4 oral mucositis (OM) according to World Health Organization (WHO) criteria.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Potential implications of adjuvant endocrine therapy for the oral health of postmenopausal women with breast cancer.
Taichman LS, Havens AM, Van Poznak CH. · · 2013 · cited 13× · PMID 22986813 · DOI 10.1007/s10549-012-2217-z
The Construction of ceRNA Regulatory Network Unraveled Prognostic Biomarkers and Repositioned Drug Candidates for the Management of Pancreatic Ductal Adenocarcinoma.
Aydin B, Okutan K, Aydogan OO, Sinha R, et al · · 2025 · PMID 40728965 · DOI 10.3390/cimb47070496

Verify or expand the search:

Other recruiting trials for Stomatitis

Currently open trials in the same condition.

NCT07400328 — Amimestrocel Injection for Preventing Severe Oral Mucositis in HSCT Patients · Phase 2 · recruiting
NCT06532279 — Testing the Addition of the Drug BMX-001, a Radioprotector, or a Placebo to the Usual Chemoradiation Therapy for Patient · Phase 2 · recruiting
NCT06071637 — Low Power Laser Therapy As Prevention Of Oral Mucositis And Oropharyngeal Pain In Patients Undergoing Allogenetic HSCT · Phase 3 · recruiting
NCT03581773 — Folic Acid Supplement Versus Placebo for Treating Mucositis Adverse Events in Metastatic Renal Cell Carcinoma Patients R · Phase 2 · 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 NCT00385515 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Mucosal Therapeutics
Last refreshed: 8 April 2009

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/NCT00385515.

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