The use of Nalcol in functional constipation

• Research type

  Research Study

• Full title

  NALCOL TREATMENT FOR FUNCTIONAL CONSTIPATION: A RANDOMISED, DOUBLE BLIND CONTROLLED TRIAL IN SECONDARY CARE

• IRAS ID

  17264

• Sponsor organisation

  Norfolk and Norwich University Hospital NHS Trust

• Eudract number

  2009-011853-42

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  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. Constipation is present in between 10 and 15 per cent of the UK population, and as many as 1% of women have chronic functional constipation which is unresponsive to dietary manipulation or laxatives. Quality of life is often severely affected. Opioid receptors are located throughout the bowel wall and are known to slow gut transit resulting in constipation. Nalcol, as an opiod antagonist, will block these effects and we hope decrease the gut transit time and improve constipation. Consenting patients, aged 18 years and over, suffering from functional constipation, refractory to standard therapy (diet and laxatives) and satisfying inclusion/exclusion criteria will be recruited. These patients will have been referred by their GPs to speciality clinics and although the study is open to both sexes we anticipate the majority of participants to be female. The study will consist of 3 parts. Period 1 is an assessment period lasting 2 weeks. Period 2 will last 4 weeks and is the treatment period. Patients will be randomised to either the active compound or a placebo. The 3rd period allows all patients to take the Nalcol and also lasts 4 weeks. Patients will be required to complete a diary card weekly and two questionnaires relating to the previous week at the end of each period. We aim to sample the faeces in a subset of patients who volunteer at the end of each of the periods. It has been shown that changes in normal colonic flora are associated with constipation and we feel that taking samples from these patients at different stages in the trial will help in the understanding of this relationship.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  09/H0304/55

• Date of REC Opinion

  8 Sep 2009

• REC opinion

  Further Information Favourable Opinion