GastroparesisPhase 2NCT01039805
Evaluation of Single Doses of GSK962040 in Critically Ill Patients With Enteral Feed Intolerance
A Phase 2 study testing GSK962040 (50 mg) and GSK962040 (75 mg) in people with Gastroparesis, run by GlaxoSmithKline at 1 site in Australia.
Trial summary
The aims of MOT112571 are to assess the pharmacodynamic effects, safety, tolerability, pharmacokinetics, and potential therapeutic benefit of single doses of GSK962040 in critically ill patients with delayed gastric emptying and who are intolerant to enteral feeding. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Gastroparesis
- What is being tested?
- GSK962040 (50 mg) and GSK962040 (75 mg)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteAustralia
- Study dates
- Dec 2009to Jul 2011
- Phase
- Phase 2
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female between 18-85 years of age, at the time consent is obtained.
- Mechanically ventilated on the Intensive Care Unit who has become intolerant of nasogastric enteral feeding.
- intolerance of nasogastric tube feeding is defined as a gastric aspirate volume (GRV) >250 mL at least 6 hours after commencing feeding at >40 mL/hr.
- Expected to remain mechanically ventilated for at least 48 hours after enrollment and expected to survive for at least 24 hours post dose of study medication.
- Subject has a nasogastric tube for enteral feeding.
- Body weight > or = 50 kg
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- Written informed consent may be obtained from a legally acceptable representative, which includes compliance with the requirements and restrictions listed in the consent form. In most cases, consent will be sought from next of kin as the subject will not be competent to give their own consent.
- Average QTcB or QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block.
- AST and ALT < 3xULN; alkaline phosphatase and bilirubin < or = 2xULN.
- Subjects who have rapidly rising aminotransferases or for whem there is not a plausible explanation for the observed elevation will not be enrolled
- LFTs will be checked for eligibility on screening and again prior to dosing with GSK962040.
Who cannot join
- Subjects that have received a gastric prokinetic agent in the previous 24 h (e.g., erythromycin, azithromycin, metoclopramide). These agents are prohibited for the duration of the study.
- Subjects whose clinical condition is deteriorating rapidly or any subject for whom the investigator does not consider there is a reasonable expectation that they will be able to complete the study.
- Subjects who are known to be infected with Hepatitis B, Hepatitis C, or HIV viruses.
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
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- Use of prohibited medications listed in Section 9.2 within the restricted timeframe relative to dosing of study medication.
- Subjects with renal failure requiring replacement therapy (dialysis or filtration).
- Subjects for whom the reason for admission to ICU was an overdose (deliberate or accidental; medicinal product or not).
- Subjects with altered upper gastrointestinal tract anatomy and subjects who have undergone upper gastrointestinal tract surgery on this admission to ICU.
- Subjects with bowel obstruction or perforation.
- Subject has a gastric pacemaker
- Subject is receiving parenteral feeding
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
- Pregnant females as determined by positive serum or urine hCG test at screening or prior to dosing.
- Lactating females.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized, Placebo Controlled Phase II Study to Evaluate the Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Single Doses of the Oral Motilin Receptor Agonist GSK962040, in Critically Ill Male and Female Patients With Enteral Feed Intolerance
The aims of MOT112571 are to assess the pharmacodynamic effects, safety, tolerability, pharmacokinetics, and potential therapeutic benefit of single doses of GSK962040 in critically ill patients with delayed gastric emptying and who are intolerant to enteral feeding.
- Conditions
- Gastroparesis
- Being tested
- GSK962040 (50 mg), Placebo, GSK962040 (75 mg)
- Keywords
- GSK962040, 13C octanoic acid breath test, pharmacokinetics, critically ill patients, gut motility, pharmacodynamics, tolerability, single dose, gastric emtpying
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK962040 (50 mg)Drug
Cohort 1 = 50 mg
PlaceboDrug
matching placebo
GSK962040 (75 mg)Drug
Cohort 2 = 75 mg
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Subjects randomized to either GSK962040 (50 mg) or placebo Receives: Drug: GSK962040 (50 mg); Drug: Placebo |
| Cohort 2 | Experimental | Subjects randomized to either GSK962040 (75 mg) or placebo Receives: Drug: Placebo; Drug: GSK962040 (75 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric emptying
Measured: 3 days
Safety and tolerability of GSK962040
Measured: 5 days
Pharmacokinetic parameters of GSK962040: Cmax, Tmax, AUC(0-inf), AUC(0-t), CL/F, V/F, and half-life
Measured: 3 days
Secondary outcomes (4)
Pre and post GSK962040 dose Gastric Residual Volume (GRV)
Measured: Duration of dosing
Pharmacokinetic parameters of paracetamol
Measured: duration of dosing
Pharmacokinetic parameters of 3OMG
Measured: duration of dosing
Plasma concentrations of motilin
Measured: duration of dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GastroparesisStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01039805
- Sponsor's protocol ID
- 112571
- Status last verified
- Jan 2017
- First submitted
- 23 Dec 2009
- Last updated
- 30 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
Chapman MJ, Deane AM, O'Connor SL, Nguyen NQ, Fraser RJ, Richards DB, Hacquoil KE, Vasist Johnson LS, Barton ME, Dukes GE. The effect of camicinal (GSK962040), a motilin agonist, on gastric emptying and glucose absorption in feed-intolerant critically ill patients: a randomized, blinded, placebo-controlled, clinical trial. Crit Care. 2016 Aug 1;20(1):232. doi: 10.1186/s13054-016-1420-4.
PubMed 27476581
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo Controlled Phase II Study to Evaluate the Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Single Doses of the Oral Motilin Receptor Agonist GSK962040, in Critically Ill Male and Female Patients With Enteral Feed Intolerance
- ClinicalTrials.gov ID
- NCT01039805
- Acronym / sponsor ID
- 112571
- Conditions
- Gastroparesis
- Keywords
- GSK962040, 13C octanoic acid breath test, pharmacokinetics, critically ill patients, gut motility, pharmacodynamics, tolerability, single dose
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 25 Dec 2009 (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.
The aims of MOT112571 are to assess the pharmacodynamic effects, safety, tolerability, pharmacokinetics, and potential therapeutic benefit of single doses of GSK962040 in critically ill patients with delayed gastric emptying and who are intolerant to enteral feeding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: GSK962040 (50 mg), Drug: PlaceboSubjects randomized to either GSK962040 (50 mg) or placebo |
| Cohort 2 | Experimental | Drug: Placebo, Drug: GSK962040 (75 mg)Subjects randomized to either GSK962040 (75 mg) or placebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female between 18-85 years of age, at the time consent is obtained.
- Mechanically ventilated on the Intensive Care Unit who has become intolerant of nasogastric enteral feeding.
- intolerance of nasogastric tube feeding is defined as a gastric aspirate volume (GRV) >250 mL at least 6 hours after commencing feeding at >40 mL/hr.
- Expected to remain mechanically ventilated for at least 48 hours after enrollment and expected to survive for at least 24 hours post dose of study medication.
- Subject has a nasogastric tube for enteral feeding.
Key exclusion criteria (16 listed)
- Subjects that have received a gastric prokinetic agent in the previous 24 h (e.g., erythromycin, azithromycin, metoclopramide). These agents are prohibited for the duration of the study.
- Subjects whose clinical condition is deteriorating rapidly or any subject for whom the investigator does not consider there is a reasonable expectation that they will be able to complete the study.
- Subjects who are known to be infected with Hepatitis B, Hepatitis C, or HIV viruses.
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
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 |
|---|---|---|
| GSK962040 (50 mg)Cohort 1 = 50 mg | Drug | Cohort 1 |
| Placebomatching placebo | Drug | Cohort 1, Cohort 2 |
| GSK962040 (75 mg)Cohort 2 = 75 mg | Drug | Cohort 2 |
Primary outcome
Gastric emptying
Time frame: 3 days
Safety and tolerability of GSK962040
Time frame: 5 days
Pharmacokinetic parameters of GSK962040: Cmax, Tmax, AUC(0-inf), AUC(0-t), CL/F, V/F, and half-life
Time frame: 3 days
4 secondary outcomes
Pre and post GSK962040 dose Gastric Residual Volume (GRV)
Time frame: Duration of dosing
Pharmacokinetic parameters of paracetamol
Time frame: duration of dosing
Pharmacokinetic parameters of 3OMG
Time frame: duration of dosing
Plasma concentrations of motilin
Time frame: duration of dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2017.
- Derived from this study: PubMed 27476581Chapman MJ, Deane AM, O'Connor SL, Nguyen NQ, Fraser RJ, Richards DB, Hacquoil KE, Vasist Johnson LS, Barton ME, Dukes GE. The effect of camicinal (GSK962040), a motilin agonist, on gastric emptying and glucose absorption in feed-intolerant critically ill patients: a randomized, blinded, placebo-controlled, clinical trial. Crit Care. 2016 Aug 1;20(1):232. doi: 10.1186/s13054-016-1420-4.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GSK962040 (50 mg) and GSK962040 (75 mg) in people with Gastroparesis, run by GlaxoSmithKline at 1 site in Australia.
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 11 inclusion and 16 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 30 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Gastric emptying (time frame: 3 days). The study lists 3 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 NCT01039805, which also lists 1 linked publication.
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 30 Jan 2017.