Determine the Safety and Efficacy of Oxy/Nal Tablets Compared to Oxy PR in Subjects With Cancer Pain

NCT01885182 | Completed Phase 3 Results

• 1 other identifier: OXN10-CN-303
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 28

Brief Summary

To Determine the Safety and Efficacy of Oxycodone / Naloxone Prolonged Release Tablets compared to Oxycodone PR in Subjects with Moderate to Severe, Chronic Cancer Pain

Conditions

Cancer; Pain

Outcome Measures

Primary Outcomes (2)

• The Change of BFI-Bowel Function Index at visit8

  BFI is the mean of NAS for the following items: * Ease of defecation * Feeling of incomplete bowel evacuation. * Personal judgment of constipation. NAS was a measure of 0-100 where 0 was easy/no difficulty/not at all and 100 was severe difficulty/very strong,total score range is 0-300.Do higher values represent a worse outcome.

  Visit8, visit8 taking place at week 4 or after early discontinuation/withdrawal from study

• The Change of BPI-SF at visit8

  Brief pain inventory short-form(BPI-SF) recorded at final visit assesses subject's average pain over the last 24 hours. score range is 0(no pain)-10(pain as bad as you can imagine).Do higher values represent a worse outcome.

  Visit8, visit8 taking place at week 4 or after early discontinuation/withdrawal from study

Secondary Outcomes (7)

• The Change of Symptoms of Constipation Based on Laxative Use From visit5 to visit8

  visit 5 (week 1) to visit8 (week 4 or early discontinue/withdrawal from study)

• The Change of Rescue Medication Use From visit5 to visit8

  visit 5 (week 1) to visit8 (week 4 or early discontinue/withdrawal from study)

• The Change of Modified Subjective Opiate Withdrawal Scale (SOWS) From Visit1 to visit3,visit1 to visit9

  Visit1(screening visit) to visit3 (day 1), visit1(screening visit) to visit9 (week 5)

• To Assess Quality of Life Based on EQ-5D

  Visit1(screening visit) to Visit8 (week 4 or after early discontinuation/withdrawal from study)

• The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit

  visit2 (day 0) to visit8 (week 4 or early discontinue/withdrawal from study)

Study Arms (2)

Oxycodone/Naloxone

EXPERIMENTAL

5/2.5mg, 10/5mg, 20/10mg or 40/20mg

Drug: Oxycodone/Naloxone

Oxycodone

ACTIVE COMPARATOR

5mg, 10mg, 20mg or 40mg

Drug: Oxycodone

Interventions

Oxycodone/Naloxone DRUG

Also known as: Targin

Oxycodone/Naloxone

Oxycodone DRUG

Also known as: OXY PR

Oxycodone

Eligibility Criteria

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

You may qualify if:

• Males \& females, at least 18 years or older with a diagnosis of cancer.
• Females less than one year post-menopausal must have a negative urine pregnancy test recorded prior to the first dose of study medication, be non-lactating, \& willing to use adequate \& highly effective method of contraception throughout the study. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently correctly such as sterilisation, implants, injectables, combined oral contraceptives, some IUDs (hormonal), sexual abstinence or vasectomised partner.
• Subjects who are receiving WHO step II or Step III analgesic medication who have constipation induced, or worsened by their opioid medication, as shown by
• the 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, respectively.
• the subject's self-assessment that their constipation was induced or worsened by their current pre-study opioid medication.
• Documented history of moderate to severe, chronic cancer pain that requires around the-clock opioid therapy (starting dose of oxycodone PR between 20-80 mg/day) \& are likely to benefit from WHO step III opioid therapy for the duration of the study. Subjects must be willing to discontinue their current opioid analgesic routine.
• Opioid medication continue at a stable or nearly stable dose in the investigator's opinion during the treatment.
• Subjects are willing to discontinue pre study laxative medication \& take study specific laxative medication.
• Subjects taking daily fibre supplementation or bulking agents are eligible if they can be maintained on a stable dose \& regimen throughout the study, \& in the investigators opinion are willing \& able to maintain adequate hydration.
• Subjects willing \& able (e.g. mental \& physical condition) to participate in all aspects of the study, including use of medication, completion of subjective evaluations, attending scheduled clinic visits, completing telephone contacts, \& compliance with protocol requirements as evidenced by providing written, informed consent.
• Subjects already taking non-opioid analgesics \& all other concomitant medications (including those for the treatment of depression) are eligible to take part in the study. However, all concomitant medications that are considered necessary for the subject's welfare should be continued at a stable dose throughout the double-blind phase of the study \& under the supervision of the investigator.
• Expected survival time \> 3 months.
• With capability of reading, understanding \& signing inform consent form \& compliance with protocol requirements.

You may not qualify if:

• Any history of hypersensitivity to oxycodone, naloxone, morphine, bisacodyl, related products \& other ingredients.
• Subjects with any situation in which opioids are contra-indicated, severe respiratory depression with hypoxia \& or hypercapnia, severe chronic obstructive pulmonary disease, cor pulmonal, severe bronchial asthma, paralytic ileus.
• Subjects with evidence of clinically significant gastrointestinal disease (e.g. paralytic ileus, peritoneal carcinosis), significant structural abnormalities of the gastrointestinal tract (e.g. scarring, obstruction etc) either related or not related to the underlying cancer or disease progression.
• Evidence of clinically significant cardiovascular, renal, hepatic or psychiatric disease, as determined by medical history, clinical laboratory tests, ECG results \& physical examination, that would place the subject at risk upon exposure to the study medication or that may confound the analysis \& or interpretation of the study results.
• Abnormal aspartate aminotransferase (AST; SGOT), alanine aminotransferase (ALT; SGPT), r-glutamyltransferase (GGT) or alkaline phosphatase levels (\>3 times the upper limit of normal) or an abnormal total bilirubin \& or creatinine level(s) (greater than 1.5 times the upper limit of normal).
• Cyclic chemotherapy in the two weeks before the screening visit or planned during the core study that has shown in the past to influence bowel function. If subjects are having their first cycle of chemotherapy during the 2 weeks before the screening visit or during the double-blind phase of the study they should be excluded from the study.
• Radiotherapy that, in the investigators opinion, would influence bowel function or pain during the double-blind phase of the study.
• Subjects with known or suspected unstable brain metastases or spinal cord compression that may require changes in steroid treatment throughout the duration of the study.
• Subjects with uncontrolled seizures.
• Subjects with increased intracranial pressure.
• In the investigator's opinion, subjects who are receiving hypnotics or other central nervous system (CNS) depressants that may pose a risk of additional CNS depression with opioid study medication.
• Subjects with myxoedema, not adequately treated hypothyroidism or Addisons disease.
• Subjects who have a confirmed diagnosis of ongoing irritable bowel syndrome(IBS).
• Surgery completed within 4 weeks prior to the start of the Screening Period, or planned surgery during the study that would influence pain or bowel function during the study or preclude completion of the study.
• Subjects receiving opioid substitution therapy for opioid addiction (e.g. methadone or buprenorphine).

Sponsors & Collaborators

• Mundipharma (China) Pharmaceutical Co. Ltd: lead

Study Sites (28)

Fuzhou General Hospital of Nanjing Military Command of PLA

Fuzhou, Fujian, 350025, China

Location

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Location

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Location

Sun yat-sen univercity cancer center

Guangzhou, Guangdong, 510060, China

Location

Hebei Medical University Fouth Hospital

Shijiazhuang, Hebei, 110001, China

Location

Harbin Cancer Hospital

Harbin, Heilongjiang, China

Location

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, 453100, China

Location

Hubei Cancer Hospital

Changsha, Hubei, 430079, China

Location

Tongji Hospital Tongji Medical College of HUST

Wuhan, Hubei, 430030, China

Location

Jiangsu Cancer hospital

Nanjing, Jiangsu, 210000, China

Location

The second hospital of Nanjing Medical university

Nanjing, Jiangsu, 310013, China

Location

Jilin Cancer Hospital

Changchun, Jilin, China

Location

The second affiliated hospital of Dalian Medical university

Dalian, Liaoning, 116023, China

Location

The First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

The central Hospital of Jinan

Jinan, Shandong, 250013, China

Location

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 200003, China

Location

Tangdu Hospital,Fourth Military Medical University

Xi’an, Shanxi, 710032, China

Location

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, 310016, China

Location

Beijing Hospital

Beijing, 100005, China

Location

307th hospital of Chinese People's medical sciences

Beijing, 100071, China

Location

Beijing Cancer Hospital

Beijing, 100142, China

Location

Peking University Third Hospital

Beijing, 100191, China

Location

General Hospital of Beijing Military

Beijing, 100700, China

Location

Pejing Union Medical College Hospital

Beijing, 100730, China

Location

Beijing Friendship Hospital

Beijing, China

Location

The first people's hospital of shanghai

Shanghai, 200080, China

Location

The sixth hospital of shanghai

Shanghai, 200233, China

Location

Tianjin Cancer Hospital

Tianjin, 300060, China

Location

MeSH Terms

Conditions

Neoplasms; Pain

Interventions

Oxycodone; Naloxone

Condition Hierarchy (Ancestors)

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: Clinical study manager
• Organization: Mundipharma (China) Pharmaceutical Co. LTD

Wei.Zhu@mundipharma.com.cn

0086-10-65636800

Study Officials

• Victoria Yu

  Mundipharma, China

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: June 19, 2013
• First Posted: June 24, 2013
• Study Start: June 1, 2013
• Primary Completion: August 30, 2015
• Study Completion: December 30, 2015
• Last Updated: October 4, 2019
• Results First Posted: September 16, 2019

Record last verified: 2019-05

Locations

CN (28)