CV - Long-term Safety of Naldemedine for the Treatment of OIC
Research type
Research Study
Full title
A Randomized Double-blind, Placebo-controlled, Parallel-group, Multicenter, Phase 3 Study to Evaluate the Long-term Safety of Naldemedine for the Treatment of Opioid-induced Constipation in Subjects with Nonmalignant Chronic Pain Receiving Opioid Therapy
IRAS ID
128572
Contact name
Bernhard Frank
Contact email
Sponsor organisation
Shionogi Inc.
Eudract number
2013-002949-11
Research summary
Moderate to severe pain can usually be controlled by a class of drugs called opioids. However, these drugs cause side effects such as constipation.
Constipation is a common condition that affects people of all ages. It can mean that a person is not passing stools (poo) regularly, or they are unable to completely empty their bowels. Constipation caused because of taking opioids can also be known as opioid induced constipation (OIC).
Opioids are effective pain management drugs however; the resulting constipation makes it difficult to continually use them on a regular basis.
Currently bowel dysfunction can be treated using medications called Methylnaltrexone bromide (MNTX) and Alvimopan.
Methylnaltrexone bromide is only indicated for patients with advanced medical illness receiving palliative care (symptom control) when response to laxative therapy is not sufficient.
Alvimopan is approved for patients who suffer from bowel obstruction after an operation, but is only indicated for short term, in-hospital use. However, neither of the two agents is indicated for use in OIC patients with chronic, non-cancer pain receiving opioid therapy on an outpatient basis.
Naldemedine is an opioid receptor antagonist discovered and being developed by Shionogi & Co. Ltd., In clinical trials, Naldemedine has produced significant, beneficial effects in treatment of opioid induced constipated patients.
This study is sponsored by Shionogi & Co. Ltd. And the purpose of the study is to see how well naldemedine works for the treatment of constipation caused by opioid medications, to assess the long term safety of naldemedine and the measure effectiveness of naldemine against placebo.
Adults between 18 and 80 years of age who suffer from OIC will be randomly assigned to one of two treatment groups:
• naldemedine tablet
• placebo tablet
This is a randomised, placebo-controlled, double−blind study meaning neither the patient nor the study doctor will know which medication is being given.
This is a multicentre study, which will take place across Europe and North America. It is anticipated that approximately 1500 patients will be recruited worldwide.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
13/NW/0831
Date of REC Opinion
11 Feb 2014
REC opinion
Further Information Favourable Opinion