Condition category
Digestive System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
16/12/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr B Antao

ORCID ID

Contact details

Surgery
Great Ormond Street Hospital
Great Ormond Street
London
WC1N 3JH
United Kingdom
+44 (0)20 7405 9200

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0012120117

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Digestive System: Nissen fundoplication

Intervention

Random allocation to (A) Retching treatment (B) Standard care.

Intervention type

Drug

Phase

Not Specified

Drug names

Trimeprazine

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/10/2002

Overall trial end date

30/06/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Children who have had Nissen fundoplication.

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/10/2002

Recruitment end date

30/06/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Surgery
London
WC1N 3JH
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Great Ormond Street Hospital for Children NHS Trust / Institute of Child Health (UK).

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16291162

Publication citations

  1. Results

    Antao B, Ooi K, Ade-Ajayi N, Stevens B, Spitz L, Effectiveness of alimemazine in controlling retching after Nissen fundoplication., J. Pediatr. Surg., 2005, 40, 11, 1737-1740, doi: 10.1016/j.jpedsurg.2005.07.054.

Additional files

Editorial Notes