A Study of Naldemedine (S-297995) for the Treatment of Opioid-Induced Constipation in Adults With Non-Malignant Chronic Pain Receiving Opioid Therapy

Shionogi

Status and phase: Completed; Phase 2

Conditions: Opioid-induced Constipation

Treatments: Drug: Placebo; Drug: Naldemedine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01443403

1107V9221

Details and patient eligibility

About

The purpose of this study is to determine efficacy and safety of naldemedine for the treatment of opioid-induced constipation in adults with non-malignant chronic pain receiving opioid therapy for ≥ 3 months.

Enrollment: 244 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects aged 18 years or older at time of informed consent with non-malignant chronic pain experiencing opioid-induced constipation
• Subjects with < 3 spontaneous bowel movements a week and experiencing bowel symptoms
• Subjects receiving chronic opioid therapy due to non-malignant pain for ≥ 3 months

Exclusion criteria

• Evidence of clinically significant gastrointestinal disease
• 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
• Severe constipation that has not been appropriately managed such that the subject is at immediate risk of developing serious complications of constipation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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244 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received placebo orally once daily for 28 days.

Treatment:

Drug: Placebo

Naldemedine 0.1 mg

Experimental group

Description:

Participants received 0.1 mg naldemedine orally once daily for 28 days.

Treatment:

Drug: Naldemedine

Naldemedine 0.2 mg

Experimental group

Description:

Participants received 0.2 mg naldemedine orally once daily for 28 days.

Treatment:

Drug: Naldemedine

Naldemedine 0.4 mg

Experimental group

Description:

Participants received 0.4 mg naldemedine orally once daily for 28 days.

Treatment:

Drug: Naldemedine