Opioid-induced ConstipationPhase 2/3NCT02574819
Study of Methylnaltrexone in Opioid-Induced Constipation Patients
A Phase 2/3 study testing Methylnaltrexone (MNTX) in people with Opioid-induced Constipation, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 12 sites in China.
Trial summary
This is a multicenter, randomized, double-blind , placebo-controlled trail to investigate the safety and efficacy of subcutaneous methylnaltrexone for treating opioid-induced constipation in patients with advanced illness. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Opioid-induced Constipation
- What is being tested?
- Methylnaltrexone (MNTX)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 198 participants
- Where
- 12 sitesChina
- Study dates
- Apr 2015to Apr 2017
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A life expectancy of 3 month or more
- Qualifying patients received opioids for analgesia for 1 week or more and a stable regimen of opioids and laxatives for 3 or more days before study entry
- Patients had opioid-induced constipation with either fewer than three laxation during the preceding week and no clinically meaningful laxation (as determined by the in investigator ) within 24h before the first study dose or no clinically meaningful laxation within 48h before the first study dose
- During the two-week trail , patients would keep their life habits (dietary fiber , fluid intake and physical activity)
- Patients volunteered for the trail
- Women of childbearing potential had negative pregnancy tests. Both male and female patients need to take effective contraceptives to avoid pregnancy.
Who cannot join
- Constipation that was not primarily caused by opioids ( as determined by the investigator)
- Mechanical gastrointestinal obstruction, an indwelling peritoneal catheter, clinically active diverticular disease , fecal impaction , acute surgical abdomen , and fecal ostomy
- Patients had the surgery plan which would effect the results of pain assessment
- Patients had hypersensitivity to methylnaltrexone , naltrexone or naloxone or if any investigational drug or experimental product
Trial locations and contacts
12 sites in 1 country.
Shiying Yu, Professor contact
Yuan Chen, Professor contact
12 sites in 1 country
China12 sites, 12 recruiting
- Recruiting
Fujian Provincial cancer Hospital
Fuzhou, Fujian, 350009
Cheng Huang, Professor, cheng671@sina.com
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Qingyuan Zhang, Professor
- Recruiting
The Second Hospital of Anhui Medical University
Hefei, Anhui, 230032
Zhendong Chen, Professor
- Recruiting
Tumor Hospital of Yunnan Province The Third Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650118
Runxiang Yang, Professor, 13888876721@163.com
- Recruiting
Linyi Cancer Hospital
Linyi, Shandong, 276000
Jianhua Shi, Professor, shijianhualy@126.com
- Recruiting
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029
Meijian Wang, Professor, wangmj8@sina.com
- Recruiting
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092
Leizhen Zheng, Professor, zhengleizhen2006@126.com
- Recruiting
Xin Hua Hospital affiliated to Shanghai Jiao Tong University School of Medicine Chongming Branch
Shanghai, Shanghai Municipality, 202150
Gang Ding, Professor
- Recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hebei, 430071
Di Deng, Professor
- Recruiting
Tangdu Hospital
Xian, Shanxi, 710038
Helong Zhang, Professor, cutdccc@126.com
- Recruiting
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, Jiangsu, 221000
Zhengqiu Zhu, Professor
- Recruiting
Henan Provincial Cancer Hospital
Zhengzhou, Henan, 451100
Wenying Deng, Professor, psc1969@sohu.com
About this study
Official title: Methylnaltrexone (MNTX) for Treatment of Opioid-induced Constipation in Advanced Illness Patients : a Multicenter, Randomized, Double-blind , Placebo-controlled Trail
This is a multicenter, randomized, double-blind , placebo-controlled trail to investigate the safety and efficacy of subcutaneous methylnaltrexone for treating opioid-induced constipation in patients with advanced illness.
Read the detailed description
Methylnaltrexone is a quaternary derivative of the pure opioid antagonists naltrexone. It is fairly lipid soluble and readily cross the blood-brain barrier. This property provides methylnaltrexone with the potential to block the undesired side-effects of opioid pain medications predominantly mediated by receptors located peripherally while sparing opioid effects mediated at receptors in the central nervous system, most importantly analgesia.
This is a multicenter, randomized, double-blind , placebo-controlled trail to investigate the safety and efficacy of subcutaneous methylnaltrexone for treating opioid-induced constipation in patients with advanced illness. The randomization schedule was used to assign patients in a 2:1 ratio to multicenter or an equal volume of placebo administered subcutaneously on alternate days for 2 weeks. The clinical trail was estimated to enroll 180 patients totally.
- Conditions
- Opioid-induced Constipation
- Being tested
- Methylnaltrexone (MNTX), Placebo
- Keywords
- opioid-induced constipation
- Medical subject headings
- Opioid-Induced Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylnaltrexone (MNTX)Drug
MNTX nearly 0.15mg/kg administered every other day for 2 weeks. Baseline laxatives and rescue laxative ( enemas/suppositories ) were allowed, but could not be administered within 4 hours of the study drug.
PlaceboDrug
Placebo administered every other day for 2 weeks. Baseline laxatives and rescue laxative ( enemas/suppositories ) were allowed, but could not be administered within 4 hours of the study drug.
| Study group | Role | What they receive |
|---|---|---|
| Drug | Experimental | Methylnaltrexone (MNTX) nearly 0.15mg/kg administered every other day for 2 weeks. Receives: Drug: Methylnaltrexone (MNTX) |
| Placebo | Placebo comparator | Placebo administered every other day for 2 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects who had the Rescue-free laxation response within 4 hours of the initial dose
Within 4 hours after the initial dose, if clinical significant bowel movement happened, the drug therapeutic effect was confirm. In the meantime, the time of bowel movement and other properties of bowel movement were recorded. The percentage of patients who had rescue-free laxation response is the primary outcome.
Measured: up to 4 hours
Secondary outcomes (4)
The proportion of subjects who had at least 2 Rescue-free laxation responses within 4 hours after each doses from the first dose to the forth dose
Record the frequency of laxation. After 1-4 dose, within 4 hours of every dose, record the dose number when bowel movement happened
Measured: up to 8 days
The proportion of subjects who had Rescue-free laxation response within 4 hours after each doses from the second dose to the last dose
Measured: up to 12 days
The proportion of subjects who had Rescue-free laxation response within 4-24h after each dose
Measured: up to 14 days
The proportion of subjects who had ≥3 laxation responses per week
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2016 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-induced ConstipationStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shiying Yu, Professor, Principal investigator, Tongji Hospital in Wuhan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02574819
- Sponsor's protocol ID
- CTTQ-MNTX
- Status last verified
- Oct 2015
- First submitted
- 8 Oct 2015
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methylnaltrexone (MNTX) for Treatment of Opioid-induced Constipation in Advanced Illness Patients : a Multicenter, Randomized, Double-blind , Placebo-controlled Trail
- ClinicalTrials.gov ID
- NCT02574819
- Acronym / sponsor ID
- CTTQ-MNTX
- Conditions
- Opioid-induced Constipation
- Keywords
- opioid-induced constipation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 14 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, randomized, double-blind , placebo-controlled trail to investigate the safety and efficacy of subcutaneous methylnaltrexone for treating opioid-induced constipation in patients with advanced illness.
Detailed description
Methylnaltrexone is a quaternary derivative of the pure opioid antagonists naltrexone. It is fairly lipid soluble and readily cross the blood-brain barrier. This property provides methylnaltrexone with the potential to block the undesired side-effects of opioid pain medications predominantly mediated by receptors located peripherally while sparing opioid effects mediated at receptors in the central nervous system, most importantly analgesia.
This is a multicenter, randomized, double-blind , placebo-controlled trail to investigate the safety and efficacy of subcutaneous methylnaltrexone for treating opioid-induced constipation in patients with advanced illness. The randomization schedule was used to assign patients in a 2:1 ratio to multicenter or an equal volume of placebo administered subcutaneously on alternate days for 2 weeks. The clinical trail was estimated to enroll 180 patients totally.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug | Experimental | Drug: Methylnaltrexone (MNTX)Methylnaltrexone (MNTX) nearly 0.15mg/kg administered every other day for 2 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo administered every other day for 2 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- A life expectancy of 3 month or more
- Qualifying patients received opioids for analgesia for 1 week or more and a stable regimen of opioids and laxatives for 3 or more days before study entry
- Patients had opioid-induced constipation with either fewer than three laxation during the preceding week and no clinically meaningful laxation (as determined by the in investigator ) within 24h before the first study dose or no clinically meaningful laxation within 48h before the first study dose
- During the two-week trail , patients would keep their life habits (dietary fiber , fluid intake and physical activity)
- Patients volunteered for the trail
Key exclusion criteria (4 listed)
- Constipation that was not primarily caused by opioids ( as determined by the investigator)
- Mechanical gastrointestinal obstruction, an indwelling peritoneal catheter, clinically active diverticular disease , fecal impaction , acute surgical abdomen , and fecal ostomy
- Patients had the surgery plan which would effect the results of pain assessment
- Patients had hypersensitivity to methylnaltrexone , naltrexone or naloxone or if any investigational drug or experimental product
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylnaltrexone (MNTX)MNTX nearly 0.15mg/kg administered every other day for 2 weeks. Baseline laxatives and rescue laxative ( enemas/suppositories ) were allowed, but could not be administered within 4 hours of the study drug. | Drug | Drug |
| PlaceboPlacebo administered every other day for 2 weeks. Baseline laxatives and rescue laxative ( enemas/suppositories ) were allowed, but could not be administered within 4 hours of the study drug. | Drug | Placebo |
Primary outcome
The proportion of subjects who had the Rescue-free laxation response within 4 hours of the initial dose
Time frame: up to 4 hours
Within 4 hours after the initial dose, if clinical significant bowel movement happened, the drug therapeutic effect was confirm. In the meantime, the time of bowel movement and other properties of bowel movement were recorded. The percentage of patients who had rescue-free laxation response is the primary outcome.
4 secondary outcomes
The proportion of subjects who had at least 2 Rescue-free laxation responses within 4 hours after each doses from the first dose to the forth dose
Time frame: up to 8 days
The proportion of subjects who had Rescue-free laxation response within 4 hours after each doses from the second dose to the last dose
Time frame: up to 12 days
The proportion of subjects who had Rescue-free laxation response within 4-24h after each dose
Time frame: up to 14 days
The proportion of subjects who had ≥3 laxation responses per week
Time frame: up to 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shiying Yu, Professor contact
Yuan Chen, Professor contact
Shiying Yu, Professor principal investigator
Tongji Hospital in Wuhan
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Methylnaltrexone (MNTX) in people with Opioid-induced Constipation, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 12 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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shiying Yu, Professor (syyu@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of subjects who had the Rescue-free laxation response within 4 hours of the initial dose (time frame: up to 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2015.