Pediatric Clinical Trial Registration and Trial Results: An Urgent Need for Improvement

Abstract Background Anal fissure is a common complication of the anorectal region and one of the most reported causes of anal pain. Acute anal fissure can be cured by surgery or medical treatment. There is an increase in the use of topical therapy for the treatment of anal fissures. A common topical drug used is Diltiazem (DTZ), a calcium-channel blocker, which relaxes the anal sphincter and thus promotes healing of the anal fissure. Moist exposed burn ointment (MEBO) is an ointment that is effective for the treatment of burns and wound healing and is becoming popular in the treatment of anal fissures. Methods This is a 1:1:1 randomized, controlled, parallel design, with endpoint measures of change in pain score, wound healing, defecation strain score and patient’s global impression of improvement. The study will be conducted at AUBMC over a 10-week period. Patients will be randomized to three treatment arms: MEBO, Diltiazem, and a combination of MEBO and Diltiazem ointments. Discussion The results of this study will allow physicians to assess the efficacy and safety of MEBO in the treatment of acute anal fissure, and also in comparison to Diltiazem. This trial will generate evidence-based conclusions regarding the use of a herbal/natural-based product (MEBO ointment) for the treatment of anal fissures. Trial registration ClinicalTrials.gov Identifier NCT04153032. Clinical Trial Registration Date: 06-NOVEMBER-2019.

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Clinical Trial Registration: The Time Has Come…

PM&R ◽

10.1016/j.pmrj.2015.11.003 ◽

2015 ◽

Vol 7 (12) ◽

pp. 1203-1204 ◽

Cited By ~ 1

Author(s):

Leighton Chan ◽

Allen W. Heinemann

Keyword(s):

Clinical Trial ◽

Trial Registration ◽

Clinical Trial Registration

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Editorial policies of MEDLINE indexed Indian journals on clinical trial registration

Indian Pediatrics ◽

10.1007/s13312-013-0092-2 ◽

2013 ◽

Vol 50 (3) ◽

pp. 339-340 ◽

Cited By ~ 1

Author(s):

Soumyadeep Bhaumik ◽

Tamoghna Biswas

Keyword(s):

Clinical Trial ◽

Trial Registration ◽

Clinical Trial Registration ◽

Editorial Policies

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Response to Letter to the Editor, “Clinical Trial Registration in Oral Health Journals”

Journal of Dental Research ◽

10.1177/0022034514563955 ◽

2014 ◽

Vol 94 (3_suppl) ◽

pp. 104S-104S

Author(s):

V. Smaïl-Faugeron ◽

H. Fron-Chabouis ◽

P. Durieux

Keyword(s):

Clinical Trial ◽

Oral Health ◽

Trial Registration ◽

Clinical Trial Registration ◽

Letter To The Editor

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Practical and conceptual issues of clinical trial registration for Brazilian researchers

Sao Paulo Medical Journal ◽

10.1590/1516-3180.2014.00441803 ◽

2015 ◽

Vol 134 (1) ◽

pp. 28-33 ◽

Cited By ~ 3

Author(s):

Carolina Gomes Freitas ◽

Thomas Fernando Coelho Pesavento ◽

Maurício Reis Pedrosa ◽

Rachel Riera ◽

Maria Regina Torloni

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

International Committee ◽

New Drugs ◽

Trial Registration ◽

Clinical Trial Registry ◽

Clinical Trial Registration ◽

Registration Process ◽

Trial History ◽

Definition Of

CONTEXT AND OBJECTIVE: Clinical trial registration is a prerequisite for publication in respected scientific journals. Recent Brazilian regulations also require registration of some clinical trials in the Brazilian Clinical Trials Registry (ReBEC) but there is little information available about practical issues involved in the registration process. This article discusses the importance of clinical trial registration and the practical issues involved in this process. DESIGN AND SETTING: Descriptive study conducted by researchers within a postgraduate program at a public university in São Paulo, Brazil. METHODS: Information was obtained from clinical trial registry platforms, article reference lists and websites (last search: September 2014) on the following topics: definition of a clinical trial, history, purpose and importance of registry platforms, the information that should be registered and the registration process. RESULTS: Clinical trial registration aims to avoid publication bias and is required by Brazilian journals indexed in LILACS and SciELO and by journals affiliated to the International Committee of Medical Journal Editors (ICMJE). Recent Brazilian regulations require that all clinical trials (phases I to IV) involving new drugs to be marketed in this country must be registered in ReBEC. The pros and cons of using different clinical trial registration platforms are discussed. CONCLUSIONS: Clinical trial registration is important and various mechanisms to enforce its implementation now exist. Researchers should take into account national regulations and publication requirements when choosing the platform on which they will register their trial.

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