Study Evaluating Safety & Efficacy of Subcutaneous Methylnaltrexone on Opioid-Induced Constipation in Cancer Subjects

Bausch Health

Status and phase: Withdrawn; Phase 4

Conditions: Opioid-Induced Constipation

Treatments: Drug: placebo; Drug: methylnaltrexone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00858754

3200K1-4006

Details and patient eligibility

About

This purpose of this study is to evaluate the safety and effectiveness of a subcutaneous (injection beneath the skin) form of methylnaltrexone in subjects who have cancer-related pain and constipation from taking opioids. The length of participation will be up to 7 weeks.

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Is a man or woman aged 18 years or older.
• Has a body weight >= 38 kg.
• Has cancer (active or in remission), and has cancer-related pain (ie, pain due to cancer or treatment of cancer).
• Has a life expectancy of >= 6 months.
• Has a performance status of 0, 1, or 2 based on the Eastern Cooperative Oncology Group (ECOG) scale.
• Is taking opioids for cancer-related pain, and not just as-needed doses.
• Has a diagnosis of OIC as determined by the investigator.
• Is willing to follow the protocol instructions on laxative use during the study.

Exclusion criteria

• Has a history of chronic constipation before starting opioids.
• Has renal disease receiving dialysis.
• Has an ostomy for stools.
• Is a pregnant or breastfeeding woman.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

0 participants in 2 patient groups, including a placebo group

Group 1 Active Drug

Experimental group

Description:

Methylnaltrexone

Treatment:

Drug: methylnaltrexone

Group 2 Non-Active Drug

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: placebo