Long Term Safety of Naldemedine

Shionogi

Status and phase: Completed; Phase 3

Conditions: Opioid-induced Constipation

Treatments: Drug: Naldemedine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01965652

1326V9235

Details and patient eligibility

About

The purpose of this study is to evaluate the long-term safety of naldemedine for the treatment of constipation due to opioid therapy.

Enrollment: 1,246 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. Subjects aged 18 to 80 years inclusive at the time of informed consent
2. Subjects must have non-malignant chronic pain treated and must have opioid induced constipation (OIC)
3. Subjects must be treated with a stable opioid regimen at a total daily dose on average of ≥ 30 mg equivalents of oral morphine sulfate
4. Subjects may or may not be on a routine laxative regimen at the time of Screening

Exclusion Criteria

1. Evidence of significant structural abnormalities of the gastrointestinal (GI) tract
2. Evidence of active medical diseases affecting bowel transit
3. History of pelvic disorders that may be a cause of constipation
4. Surgery (except for minor procedures) within 60 days of Screening
5. History of chronic constipation prior to starting analgesic medication or any potential non-opioid cause of bowel dysfunction that may be a major contributor to the constipation (e.g. mechanical GI obstruction)
6. Subjects who have never taken laxatives for the treatment of OIC
7. Current use of any prohibited medication including opioid antagonists, partial or mixed agonists/antagonists

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

1,246 participants in 2 patient groups, including a placebo group

Naldemedine

Experimental group

Description:

Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.

Treatment:

Drug: Naldemedine

Placebo

Placebo Comparator group

Description:

Participants received matching placebo tablets orally once daily for 52 weeks.

Treatment:

Drug: Placebo