NCT01957046

A Single-arm, Study to Assess the Effect and Tolerability of Standardised Laxative Therapy (SLT) for the Reversal of Opioid-induced Constipation (OIC).

A Single-arm, Open-label, Multicentre, Non-randomised, Study to Assess the Effect and Tolerability of Standardised Laxative Therapy for the Reversal of Opioid-induced Constipation in Subjects Suffering From Malignant or Non-malignant Pain That Requires Around-the-clock Opioid Therapy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: Mundipharma Research GmbH & Co KG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to assess how effective and tolerable the country specific clinical practice guidelines of SLTs are for UK, France and Sweden are. The main rationale behind this study is that well controlled comparisons of the various laxatives for the treatment of OIC are lacking. There is lack of evidence suggesting which laxative or combination of laxatives is optimal for managing OIC.

Detailed description

The study comprises of nine study visits and the total duration of the study is up to 42-52 days Potential subjects, aged 18 years and over, with OIC will be screened for entry into the study at Visit 1 Eligible subjects will attend a 7-day Screening Period (Visit 1). This will be followed by a 28-day Treatment Period (visits 2 to 8:), made up of four clinic visits scheduled 7 days apart (visits 5(day 7), 6(day 14), 7(day 21), 8(day 28): days 7 to 28) and two telephone visits (visits 3 and 4) which will take place during the first week of the Treatment Period. There will be a 7-day Follow-up Period with a follow-up phone call to conclude the study (Visit 9). Study assessment/ evaluation include vital sign measurements, ECG, safety labs, pregnancy test and physical examination assessments, AEs, Investigator and subject questionnaires and subjects daily diaries. Subjects will continue to take their prescribed pre-study opioid medication throughout the study.

Conditions

• Opioid Induced Constipation

Interventions

Type	Name	Description
DRUG	Laxative

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-08-01
• Completion: 2015-02-01
• First posted: 2013-10-08
• Last updated: 2016-05-04

Locations

1 site across 1 country: Sweden