Assess the effect and tolerability of standardised laxative therapy (SLT) for the reversal of opioid-induced constipation (OIC) in subjects suffering from malignant or non-malignant pain that requires around-the-clock opioid therapy MedDRA version: 16.1 Level: LLT Classification code 10071128 Term: Opioid induced constipation System Organ Class: 100000004856
Conditions
Interventions
Product Name: sennoside B
Pharmaceutical Form: Tablet
INN or Proposed INN: sennoside B
CAS Number: 8000021-83-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 154
Sponsors
Mundipharma Research GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects at least 18 years 2. Females less than one year post-menopausal must have a negative pregnancy test prior to the first dose of study medication, be non-lactating, and willing to use adequate and highly effective methods of contraception throughout the study. (A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as sterilisation, implants, injectables, combined oral contraceptives, some intrauterine devices ((IUDs), hormonal), sexual abstinence or vasectomised partner). 3. Documented history of malignant or non-malignant pain that requires around-the-clock opioid therapy (WHO step II/III opioid analgesics). 4. Subjects treated with WHO step II/III opioid analgesics for at least 2 weeks prior to Screening Visit (Visit 1), who will continue with the opioid(s) over the proposed study period. 5. Subjects meeting the following criteria for OIC: • Subject and Investigator confirm that the Subject’s constipation is induced, or worsened by the Subject’s opioid medication (present at Screening) • Subjects with mean BFI score > 30 at Visit 1 • Subjects with =65 years) yes F.1.3.1 Number of subjects for this age range 59
Exclusion criteria
Exclusion criteria: Medical Conditions: 1. In the Investigator’s opinion any contraindication and precautionary condition for laxative medication(s) used in the study as per the SmPC. 2. Subjects having any potential non-opioid cause of bowel dysfunction that might be a major contributor to the constipation (Refer Appendix 18.4 for examples). 3. Surgery within 2 months prior to the start of the Screening Visit (Visit 1), or planned surgery during the Screening and Treatment periods that may affect GI motility. 4. Subjects with colostomy or ileostomy. 5. Hospitalisation expected/planned within the study Period (e.g. planned hospitalisation for the treatment of a pre-existing condition before informed consent) which can affect the outcome measure analysis. Treatments/Medications: 6. Subjects presently taking, or who have taken opioid antagonists (e.g. naloxone, naltrexone and methylnaltrexone) or opioid antagonists containing products (e.g. oxycodone/naloxone, buprenorphine/naloxone, pentazocine/naloxone, tilidine/naloxone) = 30 days prior to the start of the Screening Period. 7. Subjects already taking maximum daily dose of country specific SLT (both First and Second Line SLT) on a regular basis (i.e. =4 days per week) for the treatment of OIC. 8. Subjects receiving opioid substitution therapy for opioid addiction (e.g. methadone or buprenorphine). Additional Screening Exclusion Criteria for Subjects Suffering from Non-malignant Pain: 9. Subjects who participated in a clinical research study involving a new chemical entity or an experimental drug within 30 days of study entry (defined as Visit 1). Additional Screening Exclusion Criteria for Subjects Suffering from Malignant Pain: 10. Subjects who have received a new chemical entity or an experimental drug within 30 days of study entry (defined as Visit 1). Concurrent participation in another clinical trial is not permitted except the epidemiological study performed to assess the long-term survival data. 11. Subjects with an expected life expectancy of =3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective •To assess the effect of SLT on the frequency of soft (stool of type 3, 4 or 5 on the Bristol Stool Form Scale (BSFS)) complete bowel movements (SCBMs) per week in subjects taking World Health Organisation (WHO) step II/III opioid analgesics at Visit 8 (change from baseline to the final visit) ;Secondary Objective: The study has twelve secondary objectives. Only the first four are listed here. Please refer to Section 7.3 in the Protocol (Version 2.0, 03-Sep-2013) for the full list. •To assess the effect of SLT on the frequency of soft (stool of type 3, 4 or 5 on the Bristol Stool Form Scale (BSFS)) complete bowel movements (SCBMs) and SCBMs non-straining (NS) per week in subjects taking World Health Organisation (WHO) step II/III opioid analgesics. •To assess the number of subjects taking additional laxatives (including enema) or requiring procedures (e.g. manual bowel evacuation or surgical procedure) in addition to SLT. •To assess symptoms of constipation in subjects taking SLT concomitantly with WHO step II/III opioid analgesics as measured by the Bowel Function Index (BFI). •To assess the compliance with opioids/SLT in terms of number of subjects who did not discontinue prematurely, experience dose reduction or stop opioids/SLT due to insufficient effect and/or intolerability.;Primary end point(s): Please refer to section 14.6 of protocol for full list of outcome variables;Timepoint(s) of evaluation of this end point: Please refer to section 14.6 of the protocol | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Please refer to section 14.6 of protocol for full list of outcome variables;Timepoint(s) of evaluation of this end point: Please refer to section 14.6 of the protocol | — |
Countries
Sweden, United Kingdom
Contacts
Public ContactClinical trial contact
Mundipharma Research GmbH & Co. KG
Outcome results
None listed