Immediate-Release Oxycodone Capsules Study in Cancer Pain

NCT01675622 | Completed Phase 3 Results DMC

• 1 other identifier: OXYC10-CN-303
• Study Type: interventional
• Target: 242
• Locations: 0 countries
• Sites: N/A

Brief Summary

The efficacy of dose titration of OxyNorm™(Oxycodone) immediate-release capsules versus morphine immediate-release tablets in the treatment of cancer pain.

Conditions

Cancer

Keywords

Cancer Pain

Outcome Measures

Primary Outcomes (1)

• Numerical Rating Scale (NRS)

  The numerical rating scale is the tool to assess pain level using a numerical rating scale. The primary outcome measurement is the average change of NRS score after double blind treatment between the two treatment groups. The NRS evaluates the pain level using number scale from 0 to 10. 0 means not painful and 10 means extremely painful. 1 to 3 is lightly pain, 4-6 is moderate pain and 7 to 10 is severe pain. There is no subscales used for NRS reporting.

  baseline up to 5-8 days (double blind period)

Secondary Outcomes (9)

• The Average Dose of Study Medicine Used During Double Blind Treatment Period

  baseline up to 5-8 days (double blind period)

• Brief Pain Inventory (BPI) Change From Baseline to After Double Blind Period

  baseline up to 5-8 days (double blind period)

• Times of Breakthrough Pain Occurrence

  Within 8 days after baseline

• Patient Assessments of Satisfaction for Pain Management

  baseline up to 19-22 days (open label treatment)

• Average Number of Titrations

  baseline up to 1-3 days(double blind period)

Study Arms (2)

Oxycodone Capsules for cancer pain

EXPERIMENTAL

Drug: Oxycodone

Morphine tablets for cancer pain

ACTIVE COMPARATOR

Drug: Morphine

Interventions

Oxycodone DRUG

dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days

Also known as: No other name in this study

Oxycodone Capsules for cancer pain

Morphine DRUG

Morphine tablets 10mg and 20mg, oral every 4-6 hours

Also known as: No other name

Morphine tablets for cancer pain

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of either sex aged 18 to 80 years inclusive, who with cancers of all type.
• Patients with moderate to severe cancer pain, whose pain intensity Numeric Rating Scale ≥4.
• Patients who can understand and are able to complete Numeric Rating Scale and Brief Pain Inventory assessment.
• Patients who have given written informed consent to participate in the study.

You may not qualify if:

• Patients who are pregnant, or lactating.
• Patients who are unable to manage their pain effectively with opioids.
• Patient who need ≥120mg morphine or equivalent for treatment of pain at time of study entry;
• Patients who are receiving chemotherapy, or still under the responsive period of chemotherapy (patients who are at the interval period of chemotherapy can be enrolled into study. That is to say, patients who completed chemotherapy for more than 2 weeks can enrolled, or patients has completed chemotherapy for at least one week could be enrolled at the discretion of the investigator).
• Patients who have received radio-therapy for bony metastasis, patients receiving radiotherapy within the 4 week period before study entry (patient receiving radiotherapy for area other than pain area can be enrolled) , or patients who were scheduled to receive radiotherapy for pain area during study period.
• Patients are receiving or should receive anti-convulsion drugs/anti- depression drugs considered by investigator for the treatment of neuropathy pain. Patients are receiving or should receive any analgesic other than study medicine, which including NSAIDs.
• Patients with other unstable disease, or with dysfunction of important organ.
• Patients with an ongoing infection, abscess or fever.
• Patient with serious abnormal liver/ renal function (ALT/Aspartate Transaminase/creatinine/urea nitrogen) which is higher than 3 times of upper limit;
• Paralytic or mechanical ileus;
• Persistent asthma, chronic obstructive diseases, and cor pulmonary;
• Intracranial neoplasms, and intracranial hypertension with central respiratory depression risk.
• Monoamine oxidase inhibitors (MAOIs) or same type drugs have been administered in last 2 weeks;
• Patients who are currently taking active treatment for epilepsy or arrhythmias.
• Patients with known sensitivity or record of specific or allergic reaction to oxycodone or morphine.

Sponsors & Collaborators

• Mundipharma (China) Pharmaceutical Co. Ltd: lead

MeSH Terms

Conditions

Neoplasms; Cancer Pain

Interventions

Oxycodone; Morphine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Director of R&D
• Organization: Mundipharma (China) phamaceutical CO. LTD

0086-10-65636800

Study Officials

• Shiying Yu, Prof.

  Wuhan TongJi Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2012
• First Posted: August 30, 2012
• Study Start: January 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: July 1, 2012
• Last Updated: May 21, 2018
• Results First Posted: May 21, 2018

Record last verified: 2018-04