chronic, severe pain adequately treated with Palladon® retard 8 mg or more twice daily MedDRA version: 12.0 Level: LLT Classification code 10049475 Term: Chronic pain
Conditions
Interventions
Trade Name: Palladon retard 8 mg
Pharmaceutical Form: Capsule*
INN or Proposed INN: hydromorphone
CAS Number: 71-68-1
Other descriptive name: HYDROMORPHONE HYDROCHLORIDE
Concentration unit: mg millig
Sponsors
Acino Supply AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A patient will be eligible for inclusion in this study if the following criteria apply: The patient is suffering from chronic, severe pain adequately treated with Palladon® retard 8 mg or more twice daily, The required Palladon® retard dose did not increase in the last 14 days prior to the start of the study, The daily doses of the non-opioid analgesic medication in the last 14 days prior to the start of the study could be kept constant, The patient is older than 18 years, The patient is capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the Consent Form, The patient is able to understand and follow instructions and is able to participate in the study for the entire period. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: The following criteria will automatically exclude the patient from participating in the trial: Increasing daily doses of the non-opioid analgesic medication in the last 14 days prior to the start of the study, The patient required rescue medication in the last 14 days prior to the start of the study, Non-pharmacological pain therapies, e.g. neurolysis, acupuncture, epidural anaesthesia, Planned surgery, radiation, or chemotherapy in the next 30 days, Surgery, radiation, or chemotherapy in the last 14 days prior to the start of the study, Concomitant intake of any other strong opioids (Step 3 WHO-Guidelines), Clinically relevant increasing daily doses of co-analgesics, e.g. steroids, anticonvulsants and antidepressants in the last 14 days prior to the start of the study, Any treatment which in the opinion of the responsible physician might interfere with the pain treatment, Patients with clinically significant impaired renal function, Patients with clinically significant impaired hepatic function, Patients with a clinically relevant impairment of respiratory function including presence or history of chronic obstructive lung disorder or any other serious lung disease, Pregnancy or lactation, Women with child-bearing potential who do not apply a medically accepted method of contraception (e.g. hysterectomy, sterilization, oral contraception), Known alcoholism or drug abuse, The patient has a known or suspected personal history or family history of adverse reactions or hypersensitivity to hydromorphone, Participation in another clinical trial within one month prior to enrolment or during the course of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective ist to demonstrate that the analgesic efficacy and tolerability of the new modified release formulation of hydromorphone (Hydromorphone hydrochloride 8 mg, 16 mg, and 24 mg prolonged release capsules) applied twice daily together with food is therapeutically equivalent to Palladon® retard applied twice daily together with food. ;Secondary Objective: Secondary objectives of the study are: Assessment of safety and tolerability characteristics of the new Hydromorphone hydrochloride 8 mg, 16 mg, and 24 mg prolonged release capsules by measuring the frequency, severity, and type of adverse event. ;Primary end point(s): The primary variable is the pain intensity (PI) quantified by an 11-point verbal rating scale (VRS). It will be tested whether the PI difference between the assessments of pain at the last day of each treatment period (T vs. R) is within the pre-defined acceptance range. The VRS will be recorded twice daily and the corresponding data will be used for the statistical evaluation. | — |
Countries
Germany
Outcome results
None listed