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

Opioid Induced Constipation Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of S-297995 for the Treatment of Opioid-Induced Constipation in Subjects With Non-Malignant Chronic Pain Receiving Opioid Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01443403
• Other study ID #: 1107V9221
• Status: Completed
• Phase: Phase 2
• First received: September 20, 2011
• Last updated: April 16, 2013
• Start date: August 2011
• Est. completion date: August 2012

Study information

• Verified date: April 2013
• Source: Shionogi Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine efficacy and safety of S-297995 for the treatment of opioid-induced constipation in subjects with non-malignant chronic pain receiving opioid therapy for ≥3 months

Recruitment information / eligibility

• Status: Completed
• Enrollment: 244
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain
• Constipation
• Opioid Induced Constipation

Intervention

Drug:
• Placebo once daily
Subjects will receive placebo tablets
• 0.1 mg of S-297995 once daily
Subjects will receive S-297995 tablets and placebo tablets
• 0.2 mg of S-297995 once daily
Subjects will receive S-297995 tablets and placebo tablets
• 0.4 mg of S-297995 once daily
Subjects will receive S-297995 tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shionogi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average change from baseline in the number of spontaneous bowel movements (SBMs) per week when compared to the average number of SBMs per week during the last 2 weeks of treatment period		From randomization to end of treatment period (4 weeks)	No
Secondary	Subject global satisfaction		From randomization to end of treatment period (4 weeks)	No
Secondary	Incidence of treatment emergent adverse events, adverse events		From randomization to end of study follow-up period (3 months)	Yes
Secondary	Potential for opioid withdrawal symptoms		From randomization to end of study follow-up period (3 months)	Yes