Condition category
Digestive System
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
16/11/2011
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

Mr John Scholefield

ORCID ID

Contact details

Department of Surgery
University of Nottingham
E Floor
West Block
Queen's Medical Centre
Nottingham
NG7 2UH
United Kingdom
+44 (0)115 970 9245
john.scholefield@nottingham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RBF 97XX8

Study information

Scientific title

Acronym

Study hypothesis

The proposed study will examine:
1. The physiology of anal canal mucosal blood flow and its relationship to pressures in the anal canal in patients with 1st and 2nd degree haemorrhoids compared to patients without disease
2. The effects of topical GTN formulations on anal canal pressure and its relationship to mucosal blood flow in the anal canal and in particular in 1st and 2nd degree haemorrhoids
3. The efficacy of treatment with GTN topical formulations compared to sclerotherapy or band ligation for 1st and 2nd degree haemorrhoids in a randomised trial
4. The delivery of topically applied GTN from novel formulations preparations and its optimisation

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

Treatment

Patient information sheet

Condition

Haemorrhoids

Intervention

Not provided at time of registration

Intervention type

Drug

Phase

Not Applicable

Drug names

Glyceryltrinitrate

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/1997

Overall trial end date

31/08/1998

Reason abandoned

Eligibility

Participant inclusion criteria

200 patients with 1st or 2nd degree haemorrhoidal disease attending the colorectal unit outpatient clinic.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

200

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/09/1997

Recruitment end date

31/08/1998

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Surgery
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive Trent (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

2003 results in http://www.ncbi.nlm.nih.gov/pubmed/12524411

Publication citations

  1. Results

    Scholefield JH, Bock JU, Marla B, Richter HJ, Athanasiadis S, Pröls M, Herold A, A dose finding study with 0.1%, 0.2%, and 0.4% glyceryl trinitrate ointment in patients with chronic anal fissures., Gut, 2003, 52, 2, 264-269.

Additional files

Editorial Notes