A study which assesses the effects of two pain medications: oxycodone/naloxone prolonged-release tablets (OXN PR) and oxycodone prolonged-release tablets (OxyPR) on the gastrointestinal system of subjects suffering from non-cancer pai

• Conditions: The intended indication is: Chronic severe non malignant pain, requiring opioids.; MedDRA version: 16.0Level: PTClassification code 10033371Term: PainSystem Organ Class: 10018065 - General disorders and administration site conditions; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2012-001772-11-CZ
• Lead Sponsor: Mundipharma Research GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-07
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

1. Male or female subjects at least 18 years (females less than one year post-menopausal must have a negative serum or urine 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 IUDs (Intrauterine Device, hormonal), sexual abstinence or vasoectomised partner).
2. Subjects who are receiving WHO step II/III opioid analgesic medication for the treatment of non-malignant pain and who require daily opioid treatment for pain with WHO step III opioid therapy for the duration of the study, based on Investigator’s judgement.
3. Documented history of non-malignant pain that requires around-the-clock opioid therapy (20 - 50 mg oxycodone PR equivalent per day for a minimum of study duration).
4. Subjects with constipation caused or aggravated by opioids:
• Subject’s medical need of regular intake of laxatives to have at least 3 bowel evacuations per week, or having less than 3 bowel evacuations when not taking a laxative.
• In the opinion of the subject and investigator confirm that the subjects constipation is induced, or worsened by the subjects prestudy opioid medication (present at Screening).
5. Subjects must be willing to discontinue their current opioid analgesic routine.
6. Subjects must be willing to discontinue their current laxative regimen and willing to comply with the use of bisacodyl suppository as laxative rescue medication.
7. Subjects taking daily natural dietary fiber supplementation are eligible if they can maintain their diet throughout the study, and in the investigator’s opinion are willing and able to maintain adequate hydration.
8. Subjects willing to remain stable on their routine dietary habit.
9. Subjects must be willing and able (e.g. mental and physical condition) to participate in all aspects of the study, including use of medication, completion of subjective evaluations, attending scheduled visits at pain management and gastroenterologist clinics, completing telephone contacts, and compliance with protocol requirements as evidenced by providing written, informed consent.
10. In the investigator’s opinion the subject’s non-analgesic concomitant medications, including those medications for the treatment of depression are thought to be stable, and will remain stable throughout the Double-blind Phase of the study.
11. In the investigator’s opinion the non opioid analgesic medication dose will remain stable during the Double-blind Phase.
12. Subjects, who are dissatisfied (lack of efficacy or unacceptable tolerability) with their current WHO step II/III opioid analgesic medication.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

1) Any history of hypersensitivity to oxycodone, naloxone, related products or other ingredients of the study treatments.
2) Any contraindication to oxycodone, naloxone, or any non-investigational medicinal products (NIMPs) that will be used by subjects during the study.
3) Active alcohol or drug abuse and/or history of opioid abuse.
4) Subjects receiving hypnotics or other central nervous system (CNS) depressants that, in the investigator’s opinion, may pose a risk of additional CNS depression with opioid study treatments.
5) Subjects presently taking, or who have taken naloxone and naltrexone <= 30 days prior to the start of the Screening Period.
6) Subjects receiving enemas on regular basis within the last 4 weeks prior to the start of the Screening Period.
7) Continuous systemic use of antibiotics and/or steroids within the last 4 weeks prior to the start of the Screening Period and during the study period.
8) Evidence of clinically significant cardiovascular, renal, hepatic, gastrointestinal (e.g. paralytic ileus), or psychiatric disease, as determined by medical history, clinical laboratory tests, ECG results, and physical examination, that would place the subject at risk upon exposure to the study treatments or that may confound the analysis and/or interpretation of the study results.
9) Chronic or intermittent pain that results from Fibromyalgia or Rheumatoid Arthritis.
10) Subjects with uncontrolled seizures or convulsive disorder.
11) Surgery within 2 months prior to the start of the Screening Period, or planned surgery during the 7-week Double-Blind Phase that may affect GI motility or pain.
12) Subjects suffering from chronic diarrhoea.
13) Subjects suffering from ulcerative colitis or Crohn’s disease.
14) Subjects with a diagnosis of clinically relevant hereditary or acquired autonomic neuropathies which could have an impact on and compromise study outcomes (see Section 18).
15) Subjects with a diagnosis of food intolerance (e.g. lactose, gluten), inflammatory and/or autoimmune diseases (see Section 18).
16) Subjects with untreated hypothyroidism, Addison’s disease, increase of intracranial pressure.
17) Subjects with known or suspected hereditary fructose intolerance.
18) Subjects who are unable to perform breath test.
19) Subjects having abnormal aspartate aminotransferase (AST; SGOT), alanine aminotransferase (ALT; SGPT), or alkaline phosphatase levels (> 3 times the upper limit of normal) or an abnormal total bilirubin and/or creatinine level(s) (> 1.5 times the upper limit of normal), gamma glutamyl transpeptidase (GGT or GGTP) = 3 times the upper limit of normal.
20) 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 the start of the Screening Period).
21) Subjects institutionalized by court or administrative order.
22) Subjects with a history of GI tract surgery, e.g. gastrectomy (Billroth I, Billroth II, Roux-en-Y), bariartric surgery, gastrostomy, colostomy, colectomy, ileostomy etc.).
23) Subjects receiving oral hypoglycemic drugs, with a Hb1Ac concentration > 8% at the Screening Visit (Visit 1).
24) Subjects who require insulin for the treatment of diabetes mellitus.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified