Prucalopride Effects on Subjects With Chronic Non-cancer Pain Suffering From Opioid Induced Constipation

Opioid Induced Constipation Clinical Trial

— OIC  

Official title:

A 12-week, Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Prucalopride in Subjects With Chronic Non-cancer Pain Suffering From Opioid Induced Constipation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01117051
• Other study ID #: M0001-C301
• Secondary ID: SPD555-3012009-0
• Status: Terminated
• Phase: Phase 3
• Start date: May 19, 2010
• Est. completion date: August 13, 2012

Study information

• Verified date: May 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will evaluate the efficacy, safety and tolerability of prucalopride over 12 weeks of treatment in subjects aged 18 years and older with chronic non-cancer pain, suffering from opioid induced constipation.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 174
• Est. completion date: August 13, 2012
• Est. primary completion date: August 13, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria to be assessed at screening:

1. Male or non-pregnant, non-breast-feeding female outpatient =18 years.

2. Has chronic pain of any aetiology (except cancer pain) requiring daily maintenance treatment with opioids;has been on stable daily opioid dose during at least the previous 2 weeks; and is expected to remain on stable daily dose of opioids for at least 15 weeks after Visit 1.

3. Subject is suffering from OIC (i.e. secondary to chronic opioid use).

4. Subject agrees to stop his/her laxative treatment and is willing to use rescue medication.

Main exclusion criteria to be assessed at screening:

1. Constipation is thought to be drug-induced (except for opioids)

2. Disallowed medication is being used

3. Subject was on chronic therapy for chronic constipation prior to start of opioid therapy

4. Subject is suffering from secondary causes of chronic constipation.

Related Conditions & MeSH terms

• Constipation
• Non-cancer Pain
• Opioid Induced Constipation
• Stress, Psychological

Intervention

Drug:
• placebo
placebo
• prucalopride
1 or 2 mg prucalopride once daily before breakfast

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of Subjects With an Average Frequency of >=3 Spontaneous Bowel Movements Per Week	A bowel movement (BM) was defined as spontaneous if no laxatives were taken in the 24 hours preceding that BM.	12 weeks
Secondary	Plasma Concentration of Prucalopride at Week 2		Week 2
Secondary	Plasma Concentration of Prucalopride at Week 8		Week 8