Bypass ComplicationsPhase 4OBEMO2NCT02641301

Sustained-release Morphine Pharmacokinetics in Roux-en-Y Gastric Bypass Subjects

A Phase 4 study testing Sustained release morphine sulfate, 30 mg in people with Bypass Complications, run by Hopital Lariboisière at 2 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 20 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Bypass Complications
What is being tested?: Sustained release morphine sulfate, 30 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 2 sitesFrance
Study dates: Dec 2015to Mar 2017
Phase: Phase 4
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 20 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

RYGB Group (n=12) :
Subjects who undergone RYGB for at least 24 months
Stable weight since almost one year (or weight loss below 10kg over the last year)
Control group (n=12) :
Volunteers subjects, matched for age, sex, and Body mass index
No history of bariatric surgery

Show all 10Show fewer

Same characteristics
Subjects volunteers for the study
Age 20-65 years
Written consent

Who cannot join

Known allergy to morphine or naloxone
Patients not affiliated to the french social security system
Subjects yet recruited in a study with remuneration
Abnormalities in liver function Prothrombin ratio <70% and/ or aspartate transaminase > 5 times the usual values and/ or alanine aminotransferase >5 times the usual values and/ or in renal function (creatinine clearance Modification of Diet in Renal Disease (MDRD) < 60ml/ min
Respiratory insufficiency defined by an oximetry below 90%
Pregnancy and breastfeeding

Show all 14Show fewer

Use of drugs contra-indicated or not advised with morphine:
Agonists-antagonists opioids ( buprenorphine, nalbuphine, pentazocine ), naltrexone
Alcohol intake > 30g by day
Cough medicine morphine-like ( dextromethorphan, noscapine, pholcodine )
Codeine, ethylmorphine
Other morphine agonist ( alfentanil, codeine, dextromoramide, dextropropoxyphene, dihydrocodeine, fentanyl, oxycodone, pethidin, phenoperidine, remifentanil, sufentanil, tramadol )
Barbiturates, benzodiazepines
Rifampicin

Trial locations and contacts

2 sites in 1 country.

France2 sites

Therapeutic Research Unit, Department of Internal Medicine, Hospital Lariboisiere
Paris, 75010
Hopital Pitie Salpetriere
Paris, 75013

Other trials in France

About this study

Official title: Study of the Concentrations of Long Acting Morphine After Oral Absorption in Subjects Who Underwent Gastric Bypass (OBEMO 2)

The purpose of this study is to determine whether sustained release morphine pharmacokinetics parameters in patients undergone roux-en-y gastric bypass (RYGB) differ from subjects who did not. Our hypothesis is that exposure is comparable. Indeed, in the Study OBEMO (Determinants of Oral Morphine Answer Among Obese Patients Before and After Gastric Bypass; NCT00943969) the investigators observed changes in pharmacokinetics parameters for immediate release morphine, probably due to an earlier absorption of the morphine, in agreement with the expected clinical effect of this formulation.

Read the detailed description

This is an open label study with two arms: patients undergone roux-en-y gastric bypass and volunteers who did not matched by sex, age and Body Mass Index (BMI). In the pharmacokinetic visit the subject takes an oral administration of sustained release morphine, 30 mg, then 11 samples are collected during 12 hours.

Conditions: Bypass Complications
Being tested: Sustained release morphine sulfate, 30 mg
Keywords: obesity, Roux-en-Y-gastric bypass, pharmacokinetics, Pain, morphine
Medical subject headings: Obesity, Pain

What participants receive

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

Sustained release morphine sulfate, 30 mgDrug
Also called Code : 333 236-9 ; Access market authorisation 3400933323691
A single oral administration of a capsule of sustained release morphine sulfate, 30 mg, on one day.

Study groups in NCT02641301
Study group	Role	What they receive
Subjects Roux-en-Y-gastric bypass (RYGB)	Experimental	Sustained release morphine sulfate, 30 mg Receives: Drug: Sustained release morphine sulfate, 30 mg
Control volunteers matched with RYGB	Active comparator	Sustained release morphine sulfate, 30 mg Receives: Drug: Sustained release morphine sulfate, 30 mg

What is being measured

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

Morphine area under the curve (AUC0-inf) after its oral administration according to the morphine concentration.
Measured: During the study visit: morphine concentration at time hour 0,5 ; hour 1; hour 1,5 ; hour 2; hour2,5; hour3; hour 4; hour 5; hour 6; hour 8; hour 12 after its oral administration

Secondary outcomes (6)

Area under ther curve [AUC] of morphine-3-glucuronide, morphine-6-glucuronide
Measured: During the study visit: concentration at time hour 0,5 ; hour 1; hour 1,5 ; hour 2; hour2,5; hour3; hour 4; hour 5; hour 6; hour 8; hour 12 after morphine oral administration
Time of the maximum plasma concentration [Tmax] of morphine, morphine-3-glucuronide, morphine-6-glucuronide
Measured: During the study visit: concentrations at time hour 0,5 ; hour 1; hour 1,5 ; hour 2; hour2,5; hour3; hour 4; hour 5; hour 6; hour 8; hour 12 after morphine oral administration
Observed clearance [Cl/F] of morphine, morphine-3-glucuronide, morphine-6-glucuronide
Blood samples gathered from hour 0,5 to hour 12 and urine sample gathered from the start to the end of the study visit.
Measured: During the study visit: concentrations at time 0,5h; 1h; 1,5h; 2h; 2,5h; 3h; 4h; 5h; 6h; 8h; 12h after morphine oral administration
Observed Volume of distribution [Vd / F] of morphine, morphine-3-glucuronide, morphine-6-glucuronide
Measured: During the study visit: concentrations at time hour 0,5 ; hour 1; hour 1,5 ; hour 2; hour2,5; hour3; hour 4; hour 5; hour 6; hour 8; hour 12 after morphine oral administration
Plasma Half-Life [T1 /2] of morphine, morphine-3-glucuronide, morphine-6-glucuronide
Measured: During the study visit: concentrations at time hour 0,5 ; hour 1; hour 1,5 ; hour 2; hour2,5; hour3; hour 4; hour 5; hour 6; hour 8; hour 12 after morphine oral administration
Maximum plasma concentration [Cmax] of morphine, morphine-3-glucuronide, morphine-6-glucuronide
Measured: During the study visit: concentrations at time hour 0,5 ; hour 1; hour 1,5 ; hour 2; hour2,5; hour3; hour 4; hour 5; hour 6; hour 8; hour 12 after morphine oral administration

Timeline

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

Dec 2015Mar 2017

First posted29 Dec 2015 (estimated)
Study startDec 2015
Primary completionDec 2016 (estimated)
Study completionMar 2017 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Bypass ComplicationsStudies of the same condition, open and under way.
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 4
Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02641301
Sponsor's protocol ID: OBEMO2
Acronym: OBEMO2
Status last verified: Nov 2016
First submitted: 14 Dec 2015
Last updated: 29 Nov 2016
Results posted: No
Data monitoring committee: No
Individual data sharing: Undecided

Publications

Finucane MM, Stevens GA, Cowan MJ, Danaei G, Lin JK, Paciorek CJ, Singh GM, Gutierrez HR, Lu Y, Bahalim AN, Farzadfar F, Riley LM, Ezzati M; Global Burden of Metabolic Risk Factors of Chronic Diseases Collaborating Group (Body Mass Index). National, regional, and global trends in body-mass index since 1980: systematic analysis of health examination surveys and epidemiological studies with 960 country-years and 9.1 million participants. Lancet. 2011 Feb 12;377(9765):557-67. doi: 10.1016/S0140-6736(10)62037-5. Epub 2011 Feb 3.
PubMed 21295846
Sjostrom L, Lindroos AK, Peltonen M, Torgerson J, Bouchard C, Carlsson B, Dahlgren S, Larsson B, Narbro K, Sjostrom CD, Sullivan M, Wedel H; Swedish Obese Subjects Study Scientific Group. Lifestyle, diabetes, and cardiovascular risk factors 10 years after bariatric surgery. N Engl J Med. 2004 Dec 23;351(26):2683-93. doi: 10.1056/NEJMoa035622.
PubMed 15616203
Padwal RS, Gabr RQ, Sharma AM, Langkaas LA, Birch DW, Karmali S, Brocks DR. Effect of gastric bypass surgery on the absorption and bioavailability of metformin. Diabetes Care. 2011 Jun;34(6):1295-300. doi: 10.2337/dc10-2140. Epub 2011 Apr 8.
PubMed 21478461
Skottheim IB, Stormark K, Christensen H, Jakobsen GS, Hjelmesaeth J, Jenssen T, Reubsaet JL, Sandbu R, Asberg A. Significantly altered systemic exposure to atorvastatin acid following gastric bypass surgery in morbidly obese patients. Clin Pharmacol Ther. 2009 Sep;86(3):311-8. doi: 10.1038/clpt.2009.82. Epub 2009 Jun 3.
PubMed 19494810
Hamad GG, Helsel JC, Perel JM, Kozak GM, McShea MC, Hughes C, Confer AL, Sit DK, McCloskey CA, Wisner KL. The effect of gastric bypass on the pharmacokinetics of serotonin reuptake inhibitors. Am J Psychiatry. 2012 Mar;169(3):256-63. doi: 10.1176/appi.ajp.2011.11050719.
PubMed 22407114
Raebel MA, Newcomer SR, Reifler LM, Boudreau D, Elliott TE, DeBar L, Ahmed A, Pawloski PA, Fisher D, Donahoo WT, Bayliss EA. Chronic use of opioid medications before and after bariatric surgery. JAMA. 2013 Oct 2;310(13):1369-76. doi: 10.1001/jama.2013.278344.
PubMed 24084922
Hasselstrom J, Sawe J. Morphine pharmacokinetics and metabolism in humans. Enterohepatic cycling and relative contribution of metabolites to active opioid concentrations. Clin Pharmacokinet. 1993 Apr;24(4):344-54. doi: 10.2165/00003088-199324040-00007.
PubMed 8491060
Gourlay GK. Sustained relief of chronic pain. Pharmacokinetics of sustained release morphine. Clin Pharmacokinet. 1998 Sep;35(3):173-90. doi: 10.2165/00003088-199835030-00002.
PubMed 9784932
Lloret-Linares C, Hirt D, Bardin C, Bouillot JL, Oppert JM, Poitou C, Chast F, Mouly S, Scherrmann JM, Bergmann JF, Decleves X. Effect of a Roux-en-Y gastric bypass on the pharmacokinetics of oral morphine using a population approach. Clin Pharmacokinet. 2014 Oct;53(10):919-30. doi: 10.1007/s40262-014-0163-0.
PubMed 25141973
Buchwald H, Oien DM. Metabolic/bariatric surgery worldwide 2011. Obes Surg. 2013 Apr;23(4):427-36. doi: 10.1007/s11695-012-0864-0.
PubMed 23338049
Padwal R, Brocks D, Sharma AM. A systematic review of drug absorption following bariatric surgery and its theoretical implications. Obes Rev. 2010 Jan;11(1):41-50. doi: 10.1111/j.1467-789X.2009.00614.x. Epub 2009 Jun 2.
PubMed 19493300
Skottheim IB, Jakobsen GS, Stormark K, Christensen H, Hjelmesaeth J, Jenssen T, Asberg A, Sandbu R. Significant increase in systemic exposure of atorvastatin after biliopancreatic diversion with duodenal switch. Clin Pharmacol Ther. 2010 Jun;87(6):699-705. doi: 10.1038/clpt.2010.32. Epub 2010 May 5.
PubMed 20445535
Roberts DL, Dive C, Renehan AG. Biological mechanisms linking obesity and cancer risk: new perspectives. Annu Rev Med. 2010;61:301-16. doi: 10.1146/annurev.med.080708.082713.
PubMed 19824817
Lotsch J, Weiss M, Ahne G, Kobal G, Geisslinger G. Pharmacokinetic modeling of M6G formation after oral administration of morphine in healthy volunteers. Anesthesiology. 1999 Apr;90(4):1026-38. doi: 10.1097/00000542-199904000-00016.
PubMed 10201674
Kharasch ED, Hoffer C, Whittington D, Sheffels P. Role of P-glycoprotein in the intestinal absorption and clinical effects of morphine. Clin Pharmacol Ther. 2003 Dec;74(6):543-54. doi: 10.1016/j.clpt.2003.08.011.
PubMed 14663457

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Bypass Complications trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of the Concentrations of Long Acting Morphine After Oral Absorption in Subjects Who Underwent Gastric Bypass (OBEMO 2)
ClinicalTrials.gov ID: NCT02641301
Acronym / sponsor ID: OBEMO2 / OBEMO2
Conditions: Bypass Complications
Keywords: obesity, Roux-en-Y-gastric bypass, pharmacokinetics, Pain, morphine
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 24 participants (actual)
Lead sponsor: Hopital LariboisièreUniversity, hospital or other
Study start: Dec 2015
Primary completion: Dec 2016 (estimated)
Study completion: Mar 2017 (estimated)
First posted: 29 Dec 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.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Subjects Roux-en-Y-gastric bypass (RYGB)	Experimental	Drug: Sustained release morphine sulfate, 30 mgSustained release morphine sulfate, 30 mg
Control volunteers matched with RYGB	Active comparator	Drug: Sustained release morphine sulfate, 30 mgSustained release morphine sulfate, 30 mg

Who may qualify

Ages: 20 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Subjects who undergone RYGB for at least 24 months
Stable weight since almost one year (or weight loss below 10kg over the last year)
Volunteers subjects, matched for age, sex, and Body mass index
No history of bariatric surgery
Same characteristics

Key exclusion criteria (14 listed)

Known allergy to morphine or naloxone
Patients not affiliated to the french social security system
Subjects yet recruited in a study with remuneration
Abnormalities in liver function Prothrombin ratio <70% and/ or aspartate transaminase > 5 times the usual values and/ or alanine aminotransferase >5 times the usual values and/ or in renal function (creatinine clearance Modification of Diet in Renal Disease (MDRD) < 60ml/ min
Respiratory insufficiency defined by an oximetry below 90%

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
Sustained release morphine sulfate, 30 mgAlso: Code : 333 236-9 ; Access market authorisation 3400933323691A single oral administration of a capsule of sustained release morphine sulfate, 30 mg, on one day.	Drug	Control volunteers matched with RYGB, Subjects Roux-en-Y-gastric bypass (RYGB)

Primary outcome

Morphine area under the curve (AUC0-inf) after its oral administration according to the morphine concentration.
Time frame: During the study visit: morphine concentration at time hour 0,5 ; hour 1; hour 1,5 ; hour 2; hour2,5; hour3; hour 4; hour 5; hour 6; hour 8; hour 12 after its oral administration

6 secondary outcomes

Area under ther curve [AUC] of morphine-3-glucuronide, morphine-6-glucuronide
Time frame: During the study visit: concentration at time hour 0,5 ; hour 1; hour 1,5 ; hour 2; hour2,5; hour3; hour 4; hour 5; hour 6; hour 8; hour 12 after morphine oral administration
Time of the maximum plasma concentration [Tmax] of morphine, morphine-3-glucuronide, morphine-6-glucuronide
Time frame: During the study visit: concentrations at time hour 0,5 ; hour 1; hour 1,5 ; hour 2; hour2,5; hour3; hour 4; hour 5; hour 6; hour 8; hour 12 after morphine oral administration
Observed clearance [Cl/F] of morphine, morphine-3-glucuronide, morphine-6-glucuronide
Time frame: During the study visit: concentrations at time 0,5h; 1h; 1,5h; 2h; 2,5h; 3h; 4h; 5h; 6h; 8h; 12h after morphine oral administration
Observed Volume of distribution [Vd / F] of morphine, morphine-3-glucuronide, morphine-6-glucuronide
Time frame: During the study visit: concentrations at time hour 0,5 ; hour 1; hour 1,5 ; hour 2; hour2,5; hour3; hour 4; hour 5; hour 6; hour 8; hour 12 after morphine oral administration
Plasma Half-Life [T1 /2] of morphine, morphine-3-glucuronide, morphine-6-glucuronide
Time frame: During the study visit: concentrations at time hour 0,5 ; hour 1; hour 1,5 ; hour 2; hour2,5; hour3; hour 4; hour 5; hour 6; hour 8; hour 12 after morphine oral administration
Maximum plasma concentration [Cmax] of morphine, morphine-3-glucuronide, morphine-6-glucuronide
Time frame: During the study visit: concentrations at time hour 0,5 ; hour 1; hour 1,5 ; hour 2; hour2,5; hour3; hour 4; hour 5; hour 6; hour 8; hour 12 after morphine oral administration

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2016.
Background: PubMed 21295846Finucane MM, Stevens GA, Cowan MJ, Danaei G, Lin JK, Paciorek CJ, Singh GM, Gutierrez HR, Lu Y, Bahalim AN, Farzadfar F, Riley LM, Ezzati M; Global Burden of Metabolic Risk Factors of Chronic Diseases Collaborating Group (Body Mass Index). National, regional, and global trends in body-mass index since 1980: systematic analysis of health examination surveys and epidemiological studies with 960 country-years and 9.1 million participants. Lancet. 2011 Feb 12;377(9765):557-67. doi: 10.1016/S0140-6736(10)62037-5. Epub 2011 Feb 3.
Background: PubMed 15616203Sjostrom L, Lindroos AK, Peltonen M, Torgerson J, Bouchard C, Carlsson B, Dahlgren S, Larsson B, Narbro K, Sjostrom CD, Sullivan M, Wedel H; Swedish Obese Subjects Study Scientific Group. Lifestyle, diabetes, and cardiovascular risk factors 10 years after bariatric surgery. N Engl J Med. 2004 Dec 23;351(26):2683-93. doi: 10.1056/NEJMoa035622.
Background: PubMed 21478461Padwal RS, Gabr RQ, Sharma AM, Langkaas LA, Birch DW, Karmali S, Brocks DR. Effect of gastric bypass surgery on the absorption and bioavailability of metformin. Diabetes Care. 2011 Jun;34(6):1295-300. doi: 10.2337/dc10-2140. Epub 2011 Apr 8.
Background: PubMed 19494810Skottheim IB, Stormark K, Christensen H, Jakobsen GS, Hjelmesaeth J, Jenssen T, Reubsaet JL, Sandbu R, Asberg A. Significantly altered systemic exposure to atorvastatin acid following gastric bypass surgery in morbidly obese patients. Clin Pharmacol Ther. 2009 Sep;86(3):311-8. doi: 10.1038/clpt.2009.82. Epub 2009 Jun 3.
Background: PubMed 22407114Hamad GG, Helsel JC, Perel JM, Kozak GM, McShea MC, Hughes C, Confer AL, Sit DK, McCloskey CA, Wisner KL. The effect of gastric bypass on the pharmacokinetics of serotonin reuptake inhibitors. Am J Psychiatry. 2012 Mar;169(3):256-63. doi: 10.1176/appi.ajp.2011.11050719.
Background: PubMed 24084922Raebel MA, Newcomer SR, Reifler LM, Boudreau D, Elliott TE, DeBar L, Ahmed A, Pawloski PA, Fisher D, Donahoo WT, Bayliss EA. Chronic use of opioid medications before and after bariatric surgery. JAMA. 2013 Oct 2;310(13):1369-76. doi: 10.1001/jama.2013.278344.
Background: PubMed 8491060Hasselstrom J, Sawe J. Morphine pharmacokinetics and metabolism in humans. Enterohepatic cycling and relative contribution of metabolites to active opioid concentrations. Clin Pharmacokinet. 1993 Apr;24(4):344-54. doi: 10.2165/00003088-199324040-00007.
Background: PubMed 9784932Gourlay GK. Sustained relief of chronic pain. Pharmacokinetics of sustained release morphine. Clin Pharmacokinet. 1998 Sep;35(3):173-90. doi: 10.2165/00003088-199835030-00002.
Background: PubMed 25141973Lloret-Linares C, Hirt D, Bardin C, Bouillot JL, Oppert JM, Poitou C, Chast F, Mouly S, Scherrmann JM, Bergmann JF, Decleves X. Effect of a Roux-en-Y gastric bypass on the pharmacokinetics of oral morphine using a population approach. Clin Pharmacokinet. 2014 Oct;53(10):919-30. doi: 10.1007/s40262-014-0163-0.
Background: PubMed 23338049Buchwald H, Oien DM. Metabolic/bariatric surgery worldwide 2011. Obes Surg. 2013 Apr;23(4):427-36. doi: 10.1007/s11695-012-0864-0.
Background: PubMed 19493300Padwal R, Brocks D, Sharma AM. A systematic review of drug absorption following bariatric surgery and its theoretical implications. Obes Rev. 2010 Jan;11(1):41-50. doi: 10.1111/j.1467-789X.2009.00614.x. Epub 2009 Jun 2.
Background: PubMed 20445535Skottheim IB, Jakobsen GS, Stormark K, Christensen H, Hjelmesaeth J, Jenssen T, Asberg A, Sandbu R. Significant increase in systemic exposure of atorvastatin after biliopancreatic diversion with duodenal switch. Clin Pharmacol Ther. 2010 Jun;87(6):699-705. doi: 10.1038/clpt.2010.32. Epub 2010 May 5.
Individual participant dataSharing planned: Undecided

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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.

Jean-Francois JB Bergmann, MD, PhD study director

Hopital Lariboisiere

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Sustained release morphine sulfate, 30 mg in people with Bypass Complications, run by Hopital Lariboisière at 2 sites in France.

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 10 inclusion and 14 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 29 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

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?

Morphine area under the curve (AUC0-inf) after its oral administration according to the morphine concentration. (time frame: During the study visit: morphine concentration at time hour 0,5 ; hour 1; hour 1,5 ; hour 2; hour2,5; hour3; hour 4; hour 5; hour 6; hour 8; hour 12 after its oral administration). 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 NCT02641301, which also lists 15 linked publications.

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 29 Nov 2016.