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CancerPhase 3NCT01885182

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

A Phase 3 study testing Oxycodone/Naloxone and Oxycodone in people with Cancer and Pain, run by Mundipharma (China) Pharmaceutical Co. Ltd at 28 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer, Pain
What is being tested?
Oxycodone/Naloxone and Oxycodone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
232 participants
Where
28 sitesChina
Study dates
1 Jun 2013to 30 Dec 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • Exclusion Criteria Subjects that require a dose >80 mg/day oxycodone PR at the start of the double-blind phase.
  • 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).
  • Active alcohol or drug abuse \& or history of opioid abuse.
  • Subjects suffering from diarrhoea \& or opioid withdrawal.
  • Subjects presently taking, or who have taken, naloxone ≤30 days prior to the start of the Screening Period.
  • 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), unless the subject is on data collection phase for Overall Survival.

Who cannot join

None listed.

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

China28 sites

  • Beijing Hospital

    Beijing, 100005

  • 307th hospital of Chinese People's medical sciences

    Beijing, 100071

  • Beijing Cancer Hospital

    Beijing, 100142

  • Peking University Third Hospital

    Beijing, 100191

  • General Hospital of Beijing Military

    Beijing, 100700

  • Pejing Union Medical College Hospital

    Beijing, 100730

  • Beijing Friendship Hospital

    Beijing

  • Jilin Cancer Hospital

    Changchun, Jilin

  • Hubei Cancer Hospital

    Changsha, Hubei, 430079

  • The second affiliated hospital of Dalian Medical university

    Dalian, Liaoning, 116023

  • Fuzhou General Hospital of Nanjing Military Command of PLA

    Fuzhou, Fujian, 350025

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian

  • Sun yat-sen univercity cancer center

    Guangzhou, Guangdong, 510060

  • Sir Run Run Shaw Hospital

    Hangzhou, Zhejiang, 310016

  • Harbin Cancer Hospital

    Harbin, Heilongjiang

  • The central Hospital of Jinan

    Jinan, Shandong, 250013

  • Jiangsu Cancer hospital

    Nanjing, Jiangsu, 210000

  • The second hospital of Nanjing Medical university

    Nanjing, Jiangsu, 310013

  • Shanghai Changzheng Hospital

    Shanghai, Shanghai Municipality, 200003

  • The first people's hospital of shanghai

    Shanghai, 200080

  • The sixth hospital of shanghai

    Shanghai, 200233

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110001

  • Hebei Medical University Fouth Hospital

    Shijiazhuang, Hebei, 110001

  • Tianjin Cancer Hospital

    Tianjin, 300060

  • Tongji Hospital Tongji Medical College of HUST

    Wuhan, Hubei, 430030

  • Tangdu Hospital,Fourth Military Medical University

    Xi’an, Shanxi, 710032

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang, Henan, 453100

Other trials in China

About this study

Official title: A Phase III, Randomized, Double-blind, Double-dummy, Parallel Group Study to Determine the Safety and Efficacy of Oxy/Nal Prolonged Release Tablets Compared to Oxy PR in Subjects With Moderate to Severe, Chronic Cancer Pain

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

Read the detailed description

This is a randomised, double-blind, double-dummy, parallel group study using OXN and OXY PR to treat moderate to severe, chronic cancer pain. Subjects with documented history of cancer pain that requires around the clock opioid therapy will be included. Subjects must have a medical history of constipation that was induced by, or worsened by their opioid therapy.

Conditions
Cancer, Pain
Being tested
Oxycodone/Naloxone, Oxycodone
Medical subject headings
Neoplasms, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oxycodone/NaloxoneDrug

    Also called Targin

  • OxycodoneDrug

    Also called OXY PR

Study groups in NCT01885182
Study groupRoleWhat they receive
Oxycodone/NaloxoneExperimental5/2.5mg, 10/5mg, 20/10mg or 40/20mg
Receives: Drug: Oxycodone/Naloxone
OxycodoneActive comparator5mg, 10mg, 20mg or 40mg
Receives: Drug: Oxycodone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

Secondary outcomes (7)

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

    At Visit 5(day7) and visit8(day28) number of bisacodyl taken(Number of laxative tablets took during the last 7 days (per week) and Daily number of laxative tablets took during the last 7 days (per day)*) for OXN PR and OXY PR groups.

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

  2. The Change of Rescue Medication Use From visit5 to visit8

    The average daily dose of rescue medication (Morphine Sulfate Tablet) for OXN PR group and OXY PR group at Visit 5(first week of double blind) and at Visit 8(last week of double blind).

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

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

    to compare the Modified SOWS's Change from Visit 1(day-10-0) to Visit 3(day1),Change from Visit 1 to Visit 9(day35).The SOWS was scored as the total of the 15 symptoms. each symptoms score is 0(not at all)-4(extremely).total score range is 0-60.Do higher values represent a better outcome.

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

  4. To Assess Quality of Life Based on EQ-5D

    To assess quality of life based on EQ-5D by subjects evaluation via patient dairy.the quality of life based on EQ-5D at Visit1 (day-10-0) and end of treatment Visit8(day28). The scarc range is 0(the best state you can imagine)-100(the worst state you can imagine).Do higher values represent a worse outcome.

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

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

    To compare the change of Brief pain inventory short-form (BPI-SF) 11 indivial items (except for pain in average) at visit2(day0) ,visit5(day7),visit6(day14),visit7(day21), visit8(day28). each item range (except for how much relief from treatment /medication last 24hours is 0-100%,do higher values represent a better outcome.) is 0-10, do higher values represent a worse outcome.

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

  6. The Change of Bowel Movement by Visit

    Number pf bowel movements(BM) and number of days the subjects had a bowel movement in the last 7 days before the study visit will be summarized at visit2(day0) ,visit5(day7),visit6(day14),visit7(day21), visit8(day28)..

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

  7. The Chage of Symptoms of Constipation Based on Laxative Use From visit5 to visit8

    At Visit5(day7) and visit8(day28) number of bisacodyl taken(Number of laxative tablets took during the last 7 days (per week) and Daily number of laxative tablets took during the last 7 days (per day)*) for OXN PR and OXY PR groups

    Measured: visit 5 taking place at week 1 to visit8 taking place at week 4 or early discontinue/withdrawal from study where applicable

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2013 (estimated)
  2. Study start1 Jun 2013
  3. Primary completion30 Aug 2015
  4. Study completion30 Dec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
232 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01885182
Sponsor's protocol ID
OXN10-CN-303
Status last verified
May 2019
First submitted
19 Jun 2013
Last updated
4 Oct 2019
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Oxycodone/Naloxone and Oxycodone in people with Cancer and Pain, run by Mundipharma (China) Pharmaceutical Co. Ltd at 28 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 33 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Change of BFI-Bowel Function Index at visit8 (time frame: Visit8, visit8 taking place at week 4 or after early discontinuation/withdrawal from study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01885182.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2019; AzTrials last refreshed its copy on 6 Nov 2026.

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