ISRCTN ISRCTN26938218
DOI https://doi.org/10.1186/ISRCTN26938218
Secondary identifying numbers Nalcol01
Submission date
01/12/2009
Registration date
21/07/2010
Last edited
18/04/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Mark Bignell
Scientific

c/o Mr Rhodes' Secretary
Department of General Surgery
Norfolk and Norwich University Hospitals NHS Trust
Colney Lane
Norwich
NR4 7UY
United Kingdom

Study information

Study designSingle-centre double-blind randomised parallel-group study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleNaloxone hydrochloride SR gastro-resistant sustained release capsules as a treatment for functional constipation: a randomised, double-blind controlled trial in secondary care
Study objectivesThe 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.
Ethics approval(s)Cambridgeshire 1 Research Ethics Committee, ref: H09/0304/55
Health condition(s) or problem(s) studiedConstipation
InterventionThis 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 4 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 4 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.
Intervention typeDrug
Pharmaceutical study type(s)
PhasePhase II
Drug / device / biological / vaccine name(s)Naloxone hydrochloride (Nalcol™)
Primary outcome measureComparison 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.
Secondary outcome measures1. 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 8 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
Overall study start date01/02/2010
Completion date01/02/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants120
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/02/2010
Date of final enrolment01/02/2012

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Norfolk and Norwich University Hospitals NHS Trust
Norwich
NR4 7UY
United Kingdom

Sponsor information

Norfolk and Norwich University Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

c/o Kath Andrews
Research and Development Office
Colney Lane
Norwich
NR4 7UY
England
United Kingdom

Website http://www.nnuh.nhs.uk/
ROR logo "ROR" https://ror.org/01wspv808

Funders

Funder type

Government

Norfolk and Norwich University Hospitals NHS Foundation Trust (UK) - research account (ref: E-31)

No information available

SLA Pharma AG (Switzerland) - provide active and placebo capsules

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

18/04/2017: No publications found, verifying study status with principal investigator.