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A Phase IIIb/IV, Multi-centre, Double-blind, Randomised, Placebo-controlled Parallel Group Study to Compare the Efficacy and Safety of Movicol® with Placebo in Patients with Constipation Associated with Irritable Bowel Syndrome (IBS)

开始日期2008-11-06

申办/合作机构

Norgine Pharmaceuticals Ltd.

EUCTR2004-004496-10-GB / Not yet recruiting临床2期

A Phase 2a double blind, randomised, placebo controlled, two dose study to determine the effect of orally administered methylnaltrexone (MNTX) in preventing post-operative opiate induced constipation in patients undergoing elective orthopaedic surgery - Coated MNTX

开始日期2005-04-05

申办/合作机构

Norgine Pharmaceuticals Ltd.

100 项与 Norgine Pharmaceuticals Ltd. 相关的临床结果

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0 项与 Norgine Pharmaceuticals Ltd. 相关的专利（医药）

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9

项与 Norgine Pharmaceuticals Ltd. 相关的文献（医药）

2022-01-21·Journal of Crohn's and Colitis

P432 Relationship between haemoglobin status and utility in patients with iron deficiency anaemia in inflammatory bowel disease: A post-hoc analysis of a phase, 3 clinical trial

作者: Wooton, P ; Jacob, I ; Murphy, D

AbstractBackgroundIron deficiency anaemia (IDA) can significantly impair the health-related quality of life of patients with inflammatory bowel disease (IBD), but there is little evidence demonstrating a relationship between haemoglobin (Hb) and utility values. This study aimed to estimate preference-based health state utility values from Short-Form Health Survey (SF-36) data, stratifying by treatment received, and to investigate the relationship between Hb status and health-related quality of life.MethodsA randomised phase, 3b clinical trial compared oral ferric maltol (FM) vs intravenous (IV) iron (ferric carboxymaltose (FCM)) in patients with IBD and IDA who were eligible for IV iron. This post-hoc analysis used patient-level data on SF-36 responses to generate Short-Form Six-Dimension (SF-6D) and EuroQol-5 Dimension (EQ-5D) health-state utility values using published algorithms. Utility values were further stratified by the proportion of patients achieving normalisation of Hb levels (Hb >, 13g/dL for men and >, 12g/dL for women).ResultsIn the overall study population, mean (SD) SF-6D values were, 0.67 (±0.12) at baseline and, 0.70 (±0.13) at, 52 weeks. Mapped mean EQ-5D values were, 0.77 (±0.17) at baseline and, 0.78 (±0.19) at, 52 weeks. There were no significant differences in the mean utility estimates for patients receiving FM and FCM at any assessment point (Table, 1). Of note, 45.38% of patients randomised to the FCM arm received repeat treatments after the initial course administered at baseline. In the overall study population, mean utility estimates for patients in a normalised state were significantly greater than those estimated for patients in a non-normalised state (pooled analysis of all time points): SF-6D, 0.724 (95% CI:, 0.717–0.731) vs, 0.690 (95% CI:, 0.683–0.697), respectively, Pr (|T|>|t|):, 0.001; EQ-5D, 0.834 (95% CI:, 0.826–0.842) vs, 0.792 (95% CI:, 0.782–0.802), Pr (|T|>|t|):, 0.001. No statistically significant differences were observed between treatments in the normalised or non-normalised groups.ConclusionOral ferric maltol results in similar utility scores to IV iron therapy with ferric carboxymaltose in patients with IBD eligible for intravenous iron therapy. Normalised Hb was associated with significantly better utility than non-normalised, demonstrating the value to patients of treating IDA in IBD. A cost-effectiveness analysis should be conducted to examine the incremental benefit of IV iron considering the large cost of treatment.

2019-11-02·Expert Review of Pharmacoeconomics & Outcomes Research4区 · 医学

A systematic review and cost analysis of repeat colonoscopies due to inadequate bowel cleansing in five European countries

4区 · 医学

Review

作者: Wood, Hannah ; Young, Victoria ; Amlani, Bharat ; Murphy, Daniel ; Jenks, Michelle ; McCool, Rachael

Background: Colonoscopies are carried out for a range of reasons including for the detection of colon cancer and investigation of abdominal and bowel related symptoms. Inadequate preparation can increase the burden of repeat procedures.Methods: A systematic review aimed to identify the rate of repeat colonoscopies due to inadequate bowel preparation in France, Germany, Italy, Spain and the United Kingdom. The information obtained populated a decision analytic model to estimate the cost implications of inadequate bowel cleansing in the same five countries. The model explored scenarios by comparing one and two-litre polyethylene glycol-based bowel preparation.Results: The systematic review identified 14 eligible studies reporting on the proportion of patients with inadequate bowel cleansing indicated for a repeat procedure. Data were available for Italy (27.5%-35.9%), Spain (63%) and the UK (24.5%) only. The decision analytic model demonstrates that improving the proportion of adequate bowel cleansing at first colonoscopy is likely to generate cost savings.Conclusions: Based on the available evidence, increasing the proportion of people who have adequate bowel cleansing at index colonoscopy will likely have financial benefits in Italy, Spain and the UK. A paucity of data, for France and Germany, limits the robustness of conclusions in these countries.

2018-11-02·Current Medical Research and Opinion4区 · 医学

Evaluation of the cost-effectiveness of rifaximin-α for the management of patients with hepatic encephalopathy in the United Kingdom

4区 · 医学

Article

作者: Currie, Craig J. ; Whitehouse, James ; Conway, Pete ; Berni, Ellen ; Poole, Chris ; Murphy, Daniel ; Di Maggio, Paola

OBJECTIVERifaximin-α 550 mg twice daily plus lactulose has demonstrated efficacy in reducing recurrence of episodes of overt hepatic encephalopathy (OHE) and the risk of hepatic encephalopathy (HE)-related hospitalizations compared with lactulose alone. This analysis estimated the cost effectiveness of rifaximin-α 550 mg twice daily plus lactulose versus lactulose alone in United Kingdom (UK) cirrhotic patients with OHE.METHODA Markov model was built to estimate the incremental cost-effectiveness ratio (ICER). The perspective was that of the UK National Health Service (NHS). Clinical data was sourced from a randomized controlled trial (RCT) and an open-label maintenance study in cirrhotic patients in remission from recurrent episodes of OHE. Health-related utility was estimated indirectly from disease-specific quality of life RCT data. Resource use data describing the impact of rifaximin-α on hospital admissions and length of stay for cirrhotic patients with OHE was from four single-center UK audits. Costs (2012) were derived from published sources; costs and benefits were discounted at 3.5%. The base-case time horizon was 5 years.RESULTSThe average cost per patient was £22,971 in the rifaximin-α plus lactulose arm and £23,545 in the lactulose arm, a saving of £573. The corresponding values for benefit were 2.35 quality adjusted life years (QALYs) and 1.83 QALYs per person, a difference of 0.52 QALYs. This translated into a dominant base-case ICER. Key parameters that impacted the ICER included number of hospital admissions and length of stay.CONCLUSIONRifaximin-α 550 mg twice daily in patients with recurrent episodes of OHE was estimated to generate cost savings and improved clinical outcomes compared to standard care over 5 years.

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