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ISRCTN
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ISRCTN26938218
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ClinicalTrials.gov identifier
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Public title
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The use of Nalcol™ in functional constipation
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Scientific title
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Naloxone hydrochloride SR gastro-resistant sustained release capsules as a treatment for functional constipation: a randomised, double-blind controlled trial in secondary care
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Acronym
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N/A
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Serial number at source
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Nalcol01
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Study hypothesis
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The primary objective of this study is to assess the efficacy of Nalcol™ when used as an adjunct to usual laxatives in the treatment of patients with refractory chronic constipation. The null hypothesis states that there will be no improvement in the symptoms of constipation in those participants taking Nalcol™ compared to the placebo group.
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Lay summary
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Ethics approval
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Cambridgeshire 1 Research Ethics Committee approved (ref: H09/0304/55)
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Study design
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Single centre doubleblind randomised parallel group study
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Constipation
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Participants - inclusion criteria
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1. Aged greater than 18 years
2. Male or female
3. Satisfy Rome III criteria for functional (slow transit) constipation
4. Symptoms not relieved by diet and laxatives
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Participants - exclusion criteria
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1. Severe cardiac, renal or hepatic impairment
2. Severe psychiatric disturbance
3. Mental disorder preventing adequate informed consent
4. Dilatation of the bowel (megarectum or pseudo-obstruction)
5. Concomitant medication with drugs known to cause constipation
6. Known pregnancy, suspected pregnancy, or trying to conceive
7. Currently breastfeeding
8. Currently participating (or within 1 month) in any other study
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Anticipated start date
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01/02/2010
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Anticipated end date
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01/02/2012
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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120
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Interventions
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This is a single-centre double-blind placebo controlled study of the efficacy and safety of Nalcol™ given to patients with refractory constipation attending a specialist clinic. The study is principally a phase II trial of short-term (4 weeks) effect. It is suspected that Nalcol™ will have a moderate effect, and is used here as an adjuvant to regular laxatives.
The patients will all fulfil criteria for functional constipation (as above) and will have attended a specialist gastroenterology or colorectal clinic at the Norfolk and Norwich University Hospital. They will have undergone investigation for their constipation with barium enemas and also transit studies and their basic management, including dietary and lifestyle advice and modification of laxatives, will have been instigated.
The key treatment phase (Period 2) will last 4 weeks and data over four weeks of treatment will be available. Two weeks of pre-treatment data will be collected during the screening period before randomisation (Period 1). This will allow an assessment of patient suitability and health to ensure that the inclusion criteria are met and permit examination with a rigid sigmoidoscope to obtain a rectal biopsy and stool sample. This initial period will ensure short term symptom stability and confirm patient compliance with diary completion. It will allow secondary analyses comparing pre-treatment and treated symptom scores and quality of life (QoL) data. A final phase of four weeks (Period 3) will allow all patients in the trial to evaluate the treatment and provide further observation over a more prolonged duration.
Nalcol™ is given to relieve symptoms, which may be variable from day-to-day. The tolerability of Nalcol™ tablets is expected to be comparable to that of commonly dispensed stimulant laxatives; with no significant systemic side effects. It is known that 10 mg, twice a day is effective in increasing gut motility in normal subjects and a group of patients have taken 40 mg daily and occasionally up to 60 mg daily for severe symptoms. 40 mg daily has therefore been chosen to be given to patients in this trial because of the very troublesome symptoms of constipation from which they suffer.
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Primary outcome measure(s)
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Comparison of the responders during Period 2 of the study (weeks 3 - 6) in the treatment group and those in the placebo group. Response is defined as those participants who give an assessment of 'satisfactory improvement' on at least 50% of occasions over the 4 week trial period (Period 2) to the global question on the diary card.
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Secondary outcome measure(s)
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1. Comparison of stool frequency and type, laxative use, Patient Assessment of Constipation Symptoms (PAC-SYM), and Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) between treatment and placebo groups during Period 2 of the study. PAC-SYM will be used to provide an overall symptom score; but each component will also be analysed separately to identify changes to individual symptoms. Comparison will be made between the pre and post trial transit study as an objective marker of a reduction in transit time.
2. Graphical representation of the temporal changes in stool frequency and type and analysis to assess any drop-off of effect after eight weeks of use in those receiving Nalcol™ for 8 weeks or in the whole group
3. A comparison of pre-treatment versus treatment symptom levels in the whole (n = 120), i.e., Period 1 versus Period 3
4. Comparison of stool bacterial counts between the treatment and placebo groups in the selected subset after each Period
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Sources of funding
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1. Norfolk and Norwich University Hospitals NHS Foundation Trust (UK) - research account (ref: E-31)
2. SLA Pharma AG (Switzerland) - provide active and placebo capsules
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Trial website
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Publications
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Contact name
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Mr
Mark
Bignell
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Address
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c/o Mr Rhodes' Secretary
Department of General Surgery
Norfolk and Norwich University Hospitals NHS Trust
Colney Lane
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City/town
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Norwich
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Zip/Postcode
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NR4 7UY
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Country
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United Kingdom
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Sponsor
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Norfolk and Norwich University Hospitals NHS Foundation Trust (UK)
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Address
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c/o Kath Andrews
Research and Development Office
Colney Lane
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City/town
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Norwich
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Zip/Postcode
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NR4 7UY
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Country
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United Kingdom
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Sponsor website:
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http://www.nnuh.nhs.uk/
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Date applied
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01/12/2009
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Last edited
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21/07/2010
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Date ISRCTN assigned
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21/07/2010
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