Opioid Induced Constipation MedDRA version: 9.1 Level: LLT Classification code 10021175 Term: Iatrogenic constipation
Conditions
Interventions
Product Name: Naloxone Sustained Release Capsule
Product Code: Nalcol
Pharmaceutical Form: Capsule*
INN or Proposed INN: NALOXONE HYDROCHLORIDE
Sponsors
SLA Pharma (UK) Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • All subjects must give written informed consent; • Male or female subjects, ? 18 years of age; • Taking full opioid 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Women of childbearing potential unless surgically sterile or using a highly effective method of contraception defined as those which result in low failure rate when used consistently and correctly (i.e. less than 1% per year) 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; • Patients who previously used Targin (Targinact) and developed withdrawal symptoms • 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 was recently discontinued, it 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 requiring 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and tolerability of multiple doses of Naloxone SR capsules in subjects taking opioid analgesics; Secondary Objective: 1. To determine whether Naloxone SR capsules precipitate opioid withdrawal. 2. To determine the ability of Naloxone SR capsules to improve the number of weekly spontaneous bowel movements. 3. To determine the effect of Naloxone SR capsules on quality of life. 4. To determine the effect of Naloxone SR capsules on bowel symptoms (straining, stool consistency, incomplete evacuation) ;Primary end point(s): • The incidence and severity of treatment-emergent adverse events (TEAEs) on single dosing (i.e. through to Week 3) | — |
Countries
Germany, United Kingdom
Outcome results
None listed