Naloxone SR Capsules in Patients With Opioid Induced Constipation
|ClinicalTrials.gov Identifier: NCT00984334|
Recruitment Status : Completed
First Posted : September 25, 2009
Results First Posted : December 27, 2013
Last Update Posted : December 27, 2013
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain Opioid Induced Constipation||Drug: Naloxone SR 5 mg capsules Drug: Placebo Drug: Naloxone SR 10 mg capsules Drug: Naloxone SR 20mg capsules Drug: Naloxone SR 2.5 mg capsules||Phase 2|
Naloxone has been used for many years as an IV or IM injection for the reversal of opioid effects (following opioid overdose) and has been evaluated as an oral formulation to manage opioid-induced constipation. Immediate release oral naloxone preparations have however led to reversal of opioid effects and withdrawal. This has initiated the development of prolonged (slow release) naloxone preparations which prevent the systemic levels of naloxone reaching levels where the central opioid effects may be reversed. Naloxone has a high first pass metabolism (98%) and short half life (~1hr).
The objectives of this trial are to identify the optimum dosage regime of Naloxone SR capsules based on tolerability level, to improve spontaneous bowel movement frequency, and relieve GI symptoms, in patients suffering with opioid induced constipation.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Multicentre, Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study Evaluating the Safety, Tolerability and Efficacy of Naloxone SR Capsules in Subjects With Constipation Due to Opioids, Taken for Persistent Non-Cancer Pain|
|Study Start Date :||October 2009|
|Primary Completion Date :||January 2012|
|Study Completion Date :||April 2012|
Placebo Comparator: Capsules with no active drug
Placebo capsules once daily for three weeks then twice daily for three weeks.
Active Comparator: Naloxone SR 2.5 mg capsules
Naloxone SR 2.5 mg capsules once daily for three weeks then twice daily for three weeks.
|Drug: Naloxone SR 2.5 mg capsules|
Experimental: Naloxone SR 10mg capsules
Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks.
|Drug: Naloxone SR 10 mg capsules|
Experimental: Naloxone SR 20 mg capsules
Two Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks.
|Drug: Naloxone SR 20mg capsules|
Experimental: Naloxone SR 5mg capsules
Naloxone SR 5 mg capsules once daily for three weeks then twice daily for three weeks.
|Drug: Naloxone SR 5 mg capsules|
- Incidence and Severity of Treatment Emergent Adverse Events on Single Dosing. [ Time Frame: 3 weeks ]Incidence and severity of treatment emergent adverse events on single dosing.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00984334
|Berlin, Germany, 10435|
|Frankfurt, Germany, 60311|
|Hannover, Germany, 30167|
|Mainz, Germany, 55116|
|Regionales Schmerzzentrum Wuppertal|
|Wuppertal, Germany, 42105|
|St Jame's Hospital Leeds|
|Leeds, United Kingdom, LS9 7TF|
|Norfolk & Norwich Hospital|
|Norwich, United Kingdom, NR4 7UY|
|Department of Pain Management, York Hospital|
|York, United Kingdom, LS14 6UH|
|Principal Investigator:||Karen Simpson, MD||St James University Hospital, Leeds, UK|