Naloxone SR Capsules in Patients With Opioid Induced Constipation | Completed
Naloxone SR Capsules in Patients With Opioid Induced Constipation

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Chronic Pain
  • Opioid Induced Constipation
Unfortunately contact details are not available for this trial.
Primary Contact Details
Recruitment Status
Primary Trial ID Number
For many patients taking opioids for pain relief one of the most distressing side effects is constipation. Naloxone is effective in the reversal of the effects of opioids and is used following opioid overdose. If naloxone is given by mouth it would relieve the effects of constipation but as it goes into the blood stream very quickly, it would also reverse the effects of the opioid and therefore stop the pain relief. The aim of this study is to examine a slow release formulation of naloxone to see if is can reduce constipation without reducing the pain relieving effects of the opioid.
Research Details
  • 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.
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Study Type
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

Study Arm Groups : Naloxone SR 5mg capsules, Capsules with no active drug, Naloxone SR 10mg capsules, Naloxone SR 20 mg capsules, Naloxone SR 2.5 mg capsules

Intervention Type
See Interventions above
Primary Outcome Measures
  • Incidence and Severity of Treatment Emergent Adverse Events on Single Dosing.; 3 weeks
Secondary Outcome Measures
    Sorry, this information is not available
Sorry, this information is not available
Result Reports
This is available on the website
Age Range
18 Years - N/A
Who Can Participate
Number of Participants
Sorry, this information is not available
Participant Inclusion Criteria
  • Inclusion Criteria:
  • - All subjects must give written informed consent
  • - Male or female subjects greater than 18 years of age
  • - Taking opioid full agonist therapy(oral or transdermal) for persistent non-cancer
  • pain, for at least 4 weeks prior to baseline visit
  • - Subjects with at least a 3 week history of OIC prior to baseline; where bowel
  • dysfunction is predominantly due to opioids and started following commencement of
  • opioid therapy
  • - Subjects with <3 SBMs a week and experiencing one or more bowel symptoms (incomplete
  • evacuation, straining, hard/small pellets) for 25% or more of bowel movements during
  • the screening period
  • - Subjects must be willing to discontinue all current laxative (constipation) therapy.
  • Bisacodyl will be provided and taken as required
  • Exclusion Criteria:
  • - Women of childbearing potential, unless surgically sterile or using adequate
  • contraception (either IUD, oral or depot contraceptive, or barrier plus spermicide).
  • Women using oral contraception must have started using it at least 2 months prior to
  • enrolment
  • - Women who are pregnant or breastfeeding
  • - Symptoms suggestive of non-opioid related bowel dysfunction (e.g. IBS - intermittent
  • constipation or diarrhoea) or have diarrhoea or loose stools in the 4 weeks prior to
  • baseline
  • - History of chronic constipation prior to commencing opioid therapy
  • - Gastrointestinal disorders known to affect bowel transit, or contribute to bowel
  • dysfunction (other than OIC)
  • - Chronic faecal incontinence
  • - Subjects who have a colostomy, ileostomy, or colectomy with ileorectal anastomosis
  • - Subjects with a history of neoplastic disease within 5 years (except for basal cell
  • carcinoma or non-metastatic squamous cell carcinoma of the skin)
  • - Subjects taking opioids for the management of drug addiction Subjects who do not meet
  • any of the following criteria regarding baseline medications. Analgesia (including
  • opioids and NSAIDs) should be stable throughout the trial.
  • - Any baseline analgesia must have been administered at a stable dose for a
  • minimum of 4 weeks. If non-opioid analgesia recently discontinued, must have
  • stopped at least 4 weeks prior to baseline
  • - Laxatives (outside that allowed by the protocol) are not permitted; these agents
  • must have been discontinued at the screening visit.
  • - Use of drugs known to affect gut transit time (other than opioids) are not
  • permitted (see Section 6.9 for exceptions)
  • - Use of mixed agonist/antagonist, or partial agonist opioids are not permitted
  • (e.g. buprenorphine, pentazocine, cyclazocine, nalbuphine, nalorphine)
  • - Experimental agents must have been discontinued at least 8 weeks prior to
  • screening, or for a period equivalent to 5 half-lives (t½) of the agent
  • (whichever is longer)
  • - Subjects with a history of clinically significant and/or persistent disorder
  • that, in the investigators opinion, may affect the clinical trial assessments
  • - Subjects with any laboratory tests considered clinically significant at
  • screening.
  • - Subjects not ambulatory i.e. bedridden or require use of a commode
  • - Subjects who will be unavailable for the duration of the trial, likely to be
  • non-compliant with the protocol, or who are felt to be unsuitable by the
  • Investigator for any other reason
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
St. James University Hospital
Norfolk and Norwich University Hospital
Department of Pain Management, York Hospital
LS14 6UH
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Germany, United Kingdom
Scientific 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
EudraCT Number
Not available for this trial
    Sorry, this information is not available
Other Study ID Numbers
S.L.A. Pharma AG
Key Dates

Recruitment Start Date

Oct 2009

Recruitment End Date

Jan 2012

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

24 Sep 2009

Last Updated

07 Nov 2013