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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shionogi Inc. ( Shionogi )
ClinicalTrials.gov Identifier:
NCT01443403
First received: September 20, 2011
Last updated: April 16, 2013
Last verified: April 2013
  Purpose

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


Condition Intervention Phase
Opioid Induced Constipation
Drug: Placebo once daily
Drug: 0.1 mg of S-297995 once daily
Drug: 0.2 mg of S-297995 once daily
Drug: 0.4 mg of S-297995 once daily
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Shionogi Inc.:

Primary Outcome Measures:
  • 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 [ Time Frame: From randomization to end of treatment period (4 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subject global satisfaction [ Time Frame: From randomization to end of treatment period (4 weeks) ] [ Designated as safety issue: No ]
  • Incidence of treatment emergent adverse events, adverse events [ Time Frame: From randomization to end of study follow-up period (3 months) ] [ Designated as safety issue: Yes ]
  • Potential for opioid withdrawal symptoms [ Time Frame: From randomization to end of study follow-up period (3 months) ] [ Designated as safety issue: Yes ]

Enrollment: 244
Study Start Date: August 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Subjects receiving placebo
Subjects will receive placebo orally in the morning
Drug: Placebo once daily
Subjects will receive placebo tablets
Experimental: Subjects receiving 0.1 mg of S-297995
Subjects will receive S-297995 and placebo orally in the morning
Drug: 0.1 mg of S-297995 once daily
Subjects will receive S-297995 tablets and placebo tablets
Experimental: Subjects receiving 0.2 mg of S-297995
Subjects will receive S-297995 and placebo orally in the morning
Drug: 0.2 mg of S-297995 once daily
Subjects will receive S-297995 tablets and placebo tablets
Experimental: Subjects receiving 0.4 mg of S-297995
Subjects will receive S-297995 orally in the morning
Drug: 0.4 mg of S-297995 once daily
Subjects will receive S-297995 tablets

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01443403

Sponsors and Collaborators
Shionogi
Investigators
Study Director: Shionogi Clinical Trials Administrator Clinical Support Help Line Shionogi
  More Information

No publications provided

Responsible Party: Shionogi Inc. ( Shionogi )
ClinicalTrials.gov Identifier: NCT01443403     History of Changes
Other Study ID Numbers: 1107V9221
Study First Received: September 20, 2011
Last Updated: April 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Shionogi Inc.:
Opioid Therapy
Non-Malignant Chronic Pain
Opioid-Induced Constipation

Additional relevant MeSH terms:
Constipation
Chronic Pain
Signs and Symptoms, Digestive
Signs and Symptoms
Pain
Neurologic Manifestations
Nervous System Diseases

ClinicalTrials.gov processed this record on September 16, 2014