NORGINE STUDY: PROTOCOL TZP-101-CL-P007 Version Number 1

• Research type

  Research Study

• Full title

  A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Intravenous (IV) Ulimorelin Administered Post-Operatively to Accelerate Recovery of Gastrointestinal (GI) Motility in Subjects Who Have Undergone Partial Bowel Resection Drug

• IRAS ID

  68262

• Contact name

  John Howard Scholefield

• Sponsor organisation

  Norgine Ltd.

• Eudract number

  2010-023228-26

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The purpose of this research is to find out if ulimorelin (the study medication), along with standard medical practice, can bring about the faster recovery of bowel activity following surgery and additionally reduce bowel inactivity, also known as post-operative ileus (POI). This condition can cause patient discomfort and can seriously complicate recovery from surgery. Other related complications can include increased postoperative pain, increased nausea and vomiting, delay in resuming food intake, poor wound healing, delay in postoperative mobilisation, increased risk of other postoperative complications (e.g., pneumonia, pulmonary embolism) and prolonged hospitalization. To find out how effective and safe ulimorelin is at reducing post-operative ileus (POI), patients having undergone partial bowel (intestines) surgery will be asked to participate in the study because they are the type of patients who might normally experience this kind of complication. This study consists of a screening period, an in-patient treatment period, a follow-up phone call 14 days after the bowel surgery and a follow-up clinic visit 35 days after the bowl surgery. During the hospitalization period, the doctor will assess the patient each day to decide if the study medication should continue, based on some set outcomes which mainly concern the assessment of bowel function. To determine the best dosage strength, 2 different doses of ulimorelin will be used within the study. Furthermore, for better understanding of the efficacy of the drug, a dummy study medication will also be used within the study, also known as a placebo. The 2 doses of ulimorelin will be160æg/kg and 480æg/kg. The placebo medication will look like the study medication but it will be an inactive substance. Neither the patient nor the doctor will know whether ulimorelin or placebo is being administered. If it becomes medically necessary to know whether or not a patient received ulimorelin or placebo, the doctor will be able to access this information. Patients will be randomly chosen to receive the study medication or placebo as a once-daily 30 minute intravenous infusion (infusion via a needle inserted into a vein in the arm). The first infusion will begin within one hour from the completion of the surgery and continue for up to a maximum of 7 days in a row or until bowel function recovers.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  11/H0406/2

• Date of REC Opinion

  10 Mar 2011

• REC opinion

  Further Information Favourable Opinion