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Lam C, Tan W, Leighton M, et al. Efficacy and mode of action of mesalazine in the treatment of diarrhoea-predominant irritable bowel syndrome (IBS-D): a multicentre, parallel-group, randomised placebo-controlled trial. Southampton (UK): NIHR Journals Library; 2015 Mar. (Efficacy and Mechanism Evaluation, No. 2.2.)

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Efficacy and mode of action of mesalazine in the treatment of diarrhoea-predominant irritable bowel syndrome (IBS-D): a multicentre, parallel-group, randomised placebo-controlled trial.

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Chapter 4Main outcome measures

Clinical outcomes

Primary outcome

  1. Daily mean stool frequency during weeks 11–12 of the treatment period.

Secondary outcomes (all assessed during weeks 11–12 of the treatment period)

  1. Average daily severity of abdominal pain on a 0–10 scale.
  2. Days with urgency during weeks 11–12 post randomisation.
  3. Mean stool consistency using BSFS.
  4. Global satisfaction with control of IBS symptoms, as assessed from the answer to the question ‘Have you had satisfactory relief of your IBS symptoms this week? Yes/no’.

Ancillary secondary end points

  1. European Quality of Life-5 Dimensions (EQ-5D).
  2. Centers for Disease Control and Prevention health-related quality of life Healthy Days Core Module (CDC HRQOL4).
  3. Hospital Anxiety and Depression Scale (HADS).
  4. Patient Health Questionnaire 15 (PHQ-15).

Safety end points

  1. AEs related to the trial treatment.
  2. Withdrawal from the trial treatment as a result of AEs.

Mechanistic outcomes

Primary outcome

  1. Mast cell numbers (mean percentage area stained) at week 12.

Secondary outcomes

  1. Mast cell tryptase release during 6-hour biopsy incubation.
  2. IL-1β, TNF-α, histamine and 5-HT secretion during same incubation.
  3. Small bowel tone assessed by volume of fasting small bowel water.
  4. Faecal tryptases and calprotectin.
  5. Difference in primary outcome measure between those with different TNFSF15 polymorphism will be assessed using analysis of variance (ANOVA).
Copyright © Queen’s Printer and Controller of HMSO 2015. This work was produced by Lam et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.

Included under terms of UK Non-commercial Government License.

Bookshelf ID: NBK280109
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