3200K1-4000: MNTX in Adults with Advanced Illness and OIC

• Research type

  Research Study

• Full title

  A Randomized, Double-Blind, Placebo-Controlled, Study of a Fixed Dose of Subcutaneous Methylnaltrexone in Adults With Advanced Illness and Opioid-Induced Constipation: Efficacy, Safety and Additional Health Outcomes

• IRAS ID

  4395

• Contact name

  Andrew Davies

• Sponsor organisation

  Salix Pharmaceuticals, Inc.

• Eudract number

  2007-000854-30

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  NCT00672477

• Research summary

  This research study will involve subjects who have terminal / advanced medical conditions and opioid-induced constipation (OIC). OIC is constipation that develops in people who are taking opioid medications for pain or other symptoms. Constipation consists of infrequent, difficult, or incomplete bowel movements, straining, hard dry stools, and may also include abdominal cramps, bloating, feeling sick, loss of appetite, and heartburn. The purpose of this study is to continue to learn about the experimental drug, methylnaltrexone (MNTX). The study will help determine if MNTX is safe and effective in people with terminal / advanced medical conditions and OIC. It will also help determine how MNTX affects symptoms of constipation and how it affects the quality of life terminally ill people with OIC experience. The study will also try to understand the experience of family members, friends and nurses who take care of terminally ill patients with OIC. Subjects will sign an informed consent form before any tests or examinations are done and before any questions are asked. Each subject’s suitability for the study will be assessed during a screening visit. Study medication used in this study is either MNTX or placebo. A placebo looks like the drug being tested, but does not have any active drug in it. Study medication will be given as an injection under the skin every other day for 2 weeks. There will be a one in two (50%) chance that subjects will receive placebo, and a 50% chance that they will receive MNTX. The impact of MNTX on subject-reported and other constipation-specific outcomes will be measured using various questionnaires throughout the study. Subjects who complete the 2 week treatment period will either be followed up 15 to 21 days after their last injection, or will have the option of entering an extension study (3200K1-4001-WW).

• REC name

  London - Central Research Ethics Committee

• REC reference

  08/H0718/65

• Date of REC Opinion

  3 Nov 2008

• REC opinion

  Further Information Favourable Opinion