3200K1-4001: Extension of MNTX in Adults with Advanced Illness and OIC

• Research type

  Research Study

• Full title

  Open-Label Extension Study to Assess the Safety of a Fixed Dose of Subcutaneous Methylnaltrexone in Subjects With Advanced Illness and Opioid-Induced Constipation

• IRAS ID

  4622

• Contact name

  Andrew Davies

• Sponsor organisation

  Salix Pharmaceuticals, Inc.

• Eudract number

  2007-006107-20

• Clinicaltrials.gov Identifier

  NCT00672139

• 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 is an extension of study 3200K1-4000-WW (to determine if MNTX is safe and effective in people with terminal / advanced medical conditions and OIC and to determine how MNTX affects symptoms of constipation and how it affects the quality of life terminally ill people with OIC experience). The current study will collect additional safety data and is designed to make potential comfort available to subjects who have participated in the efficacy study (3200K1-4000-WW). 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 MNTX. Study medication will be given as an injection under the skin when required for up to 10 weeks. Subjects will undergo safety assessments on a regular schedule during the study. Data on adverse events, vital signs, laboratory studies, bowel movement timing, timing of dose administration, and concomitant medications will be collected.

• REC name

  London - Central Research Ethics Committee

• REC reference

  08/H0718/66

• Date of REC Opinion

  4 Nov 2008

• REC opinion

  Further Information Favourable Opinion