GastroparesisPhase 2NCT00861809
The Effect of Single Doses of the Motilin Receptor Agonist GSK962040 in Type I Diabetic Patients With Gastroparesis
A Phase 2 study testing GSK962040 25 mg, GSK962040 50 mg and GSK962040 1250 mg in people with Gastroparesis, run by GlaxoSmithKline at 2 sites in 2 countries.
Trial summary
The purpose of this study is to assess the pharmacodynamic effects (gastric emptying), safety, tolerability, and pharmacokinetics of single doses of GSK962040 in Type 1 diabetic patients with gastroparesis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastroparesis
- What is being tested?
- GSK962040 25 mg, GSK962040 50 mg and GSK962040 1250 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2009to Nov 2010
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Controlled Type 1 Diabetes Mellitus (glucose < 250 mg/dL) with onset < 30 years of age.
- Male or female between 18 and 70 years of age, inclusive.
- Patient has documented diagnosis of moderate to severe gastroparesis (> 30% at 2 h as determined by scintigraphy; or t1/2b > 109 min as determined by 13C-octanoic acid breath test). All of the following apply:
- Confirmed delayed gastric emptying (properly conducted gastric emptying assessments within last 6 months acceptable) AND a minimum 3 month history of relevant symptoms for gastroparesis (e.g., chronic postprandial fullness, postprandial nausea, vomiting)
- A female patient is eligible to participate if she is of:
- Non-childbearing potential
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- Child-bearing potential and agrees to use contraception for at least 4 days following the last dose of study medication.
- Male patients must agree to use contraception from the time of the first dose of study medication through at least 4 days after the last dose of study medication.
- Body weight ≤110 kg and BMI < 32.0 kg/m2 (inclusive).
- Patient has never had a gastrectomy, nor major gastric surgical procedure or any evidence of bowel obstruction within the previous 12 months
- Dosage of any concomitant medications has been stable for at least 3 weeks, except for routine adjustments in daily insulin treatments
- HbA1c level is ≤ 10.0%
- Calculated creatinine clearance > or equal to 50 ml/min
- QTcB or QTcF < 450 msec or QTc<480msec in patients with Bundle Branch Block based on single or average QTc value of triplicate values obtained over a brief recording period.
- AST, ALT, alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Who cannot join
- Patient has acute severe gastroenteritis
- Patient has a gastric pacemaker
- Patient is on chronic parenteral feeding
- Patient has daily persistent severe vomiting
- Patient has pronounced dehydration
- Patient has had clinical diabetic ketoacidosis in last 4 weeks
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- Patient has a history of eating disorders (anorexia nervosa, binge eating, bulimia)
- Use of medications potentially influencing upper gastrointestinal motility or appetite within one week of the study (e.g., prokinetic drugs, macrolide antibiotics (erythromycin))
- Patient is taking opiates.
- Use of prohibited medications listed in Section 9.2 within the restricted timeframe relative to the first dose of study medication.
- History or presence of clinically significant gastro-intestinal, hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
- Presence of thyroid dysfunction (NOTE: patients with abnormal TSH at screening/baseline are not eligible. Patients with a history of hypothyroidism on a stable dose of thyroid replacement therapy are eligible to participate in the study).
- The patient 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).
- 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.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- Pregnant females as determined by positive serum or urine hCG test (from the first urine of the day) at screening or prior to dosing.
- Lactating or pregnant females.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Patients deemed unable to comply with the procedures outlined in the protocol may be excluded at the Investigator's discretion.
- For male volunteers: An unwillingness of the male patient to comply with the contraception requirements listed in Section 8.1, from the time of the first dose of study medication until at least 4 days following administration of the last dose of study medication.
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Multicenter, Double-Blind, Randomized Placebo-Controlled Phase II Study to Evaluate the Pharmacodynamics, Safety, Tolerability, and PK of Single Doses of the Oral Motilin Receptor Agonist GSK962040, in Type 1 Diabetic Male and Female Patients With Gastroparesis
The purpose of this study is to assess the pharmacodynamic effects (gastric emptying), safety, tolerability, and pharmacokinetics of single doses of GSK962040 in Type 1 diabetic patients with gastroparesis.
- Conditions
- Gastroparesis
- Being tested
- GSK962040 25 mg, Placebo, GSK962040 50 mg, GSK962040 1250 mg
- Keywords
- single dose, gut motility, Type I Diabetes Mellitus patients, tolerability, phase II, 13C octanoic acid breath test, pharmacodynamics, gastric emtpying, pharmacokinetics
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK962040 25 mgDrug
25 mg
PlaceboDrug
placebo comparator
GSK962040 50 mgDrug
50 mg
GSK962040 1250 mgDrug
125 mg
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 Period 1 | Experimental | All patients will receive placebo and 2 of the 3 possible doses of GSK962040 in a randomized, double blind, placebo controlled, incomplete block, three period crossover design. Receives: Drug: GSK962040 25 mg; Drug: Placebo; Drug: GSK962040 50 mg; Drug: GSK962040 1250 mg |
| Cohort 1 Period 2 | Experimental | All patients will receive placebo and 2 of the 3 possible doses of GSK962040 in a randomized, double blind, placebo controlled, incomplete block, three period crossover design. Receives: Drug: GSK962040 25 mg; Drug: Placebo; Drug: GSK962040 50 mg; Drug: GSK962040 1250 mg |
| Cohort 1 Period 3 | Experimental | All patients will receive placebo and 2 of the 3 possible doses of GSK962040 in a randomized, double blind, placebo controlled, incomplete block, three period crossover design. Receives: Drug: GSK962040 25 mg; Drug: Placebo; Drug: GSK962040 50 mg; Drug: GSK962040 1250 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric emptying, as measured by the 13C octanoic acid breath test (Gastric half emptying time (t1/2b), Duration of the lag time (tlag), Gastric evacuation coefficient (GEC))
Measured: 1.5 h post dose to 5.5 h post dose
Safety and tolerability of GSK962040 (Change from baseline and number of patients outside the normal range for blood pressure, heart rate, 12-lead ECG parameters)
Measured: 2 h post dose
Pharmacokinetic parameters of GSK962040: Cmax, Tmax, AUC(0-t), AUC(0-inf) for single-dose, CL/F, V/F, and, if possible, half-life
Measured: 24 h post dose
Safety and tolerability of GSK962040 (Adverse events)
Measured: 6 weeks
Safety and tolerability of GSK962040 (Change from baseline in clinical chemistry and hematology parameters)
Measured: 24 h post dose
Secondary outcomes (4)
Bowel movement parameters (Time to first bowel movement after first dose, Bowel movement count, Stool consistency (Bristol Stool Form scale))
Measured: 24 h post dose
PK/PD relationship of PP, plasma glucagon, GLP-1, and ghrelin after a single dose of GSK962040.
Measured: 0-6 h post dose
Plasma glucose
Measured: 24 h post dose
Food intake
Measured: 24 h post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2009 (estimated)
- Study startJun 2009
- Primary completionNov 2010
- Study completionNov 2010
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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 11 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
- NCT00861809
- Sponsor's protocol ID
- 111809
- Status last verified
- Jan 2017
- First submitted
- 26 Feb 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
Hellstrom PM, Tack J, Johnson LV, Hacquoil K, Barton ME, Richards DB, Alpers DH, Sanger GJ, Dukes GE. The pharmacodynamics, safety and pharmacokinetics of single doses of the motilin agonist, camicinal, in type 1 diabetes mellitus with slow gastric emptying. Br J Pharmacol. 2016 Jun;173(11):1768-77. doi: 10.1111/bph.13475. Epub 2016 Apr 13.
PubMed 26924243
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 Multicenter, Double-Blind, Randomized Placebo-Controlled Phase II Study to Evaluate the Pharmacodynamics, Safety, Tolerability, and PK of Single Doses of the Oral Motilin Receptor Agonist GSK962040, in Type 1 Diabetic Male and Female Patients With Gastroparesis
- ClinicalTrials.gov ID
- NCT00861809
- Acronym / sponsor ID
- 111809
- Conditions
- Gastroparesis
- Keywords
- single dose, gut motility, Type I Diabetes Mellitus patients, tolerability, phase II, 13C octanoic acid breath test, pharmacodynamics, gastric emtpying
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 13 Mar 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 purpose of this study is to assess the pharmacodynamic effects (gastric emptying), safety, tolerability, and pharmacokinetics of single doses of GSK962040 in Type 1 diabetic patients with gastroparesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 Period 1 | Experimental | Drug: GSK962040 25 mg, Drug: Placebo, Drug: GSK962040 50 mg, Drug: GSK962040 1250 mgAll patients will receive placebo and 2 of the 3 possible doses of GSK962040 in a randomized, double blind, placebo controlled, incomplete block, three period crossover design. |
| Cohort 1 Period 2 | Experimental | Drug: GSK962040 25 mg, Drug: Placebo, Drug: GSK962040 50 mg, Drug: GSK962040 1250 mgAll patients will receive placebo and 2 of the 3 possible doses of GSK962040 in a randomized, double blind, placebo controlled, incomplete block, three period crossover design. |
| Cohort 1 Period 3 | Experimental | Drug: GSK962040 25 mg, Drug: Placebo, Drug: GSK962040 50 mg, Drug: GSK962040 1250 mgAll patients will receive placebo and 2 of the 3 possible doses of GSK962040 in a randomized, double blind, placebo controlled, incomplete block, three period crossover design. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Controlled Type 1 Diabetes Mellitus (glucose < 250 mg/dL) with onset < 30 years of age.
- Male or female between 18 and 70 years of age, inclusive.
- Patient has documented diagnosis of moderate to severe gastroparesis (> 30% at 2 h as determined by scintigraphy; or t1/2b > 109 min as determined by 13C-octanoic acid breath test). All of the following apply:
- Confirmed delayed gastric emptying (properly conducted gastric emptying assessments within last 6 months acceptable) AND a minimum 3 month history of relevant symptoms for gastroparesis (e.g., chronic postprandial fullness, postprandial nausea, vomiting)
- A female patient is eligible to participate if she is of:
Key exclusion criteria (21 listed)
- Patient has acute severe gastroenteritis
- Patient has a gastric pacemaker
- Patient is on chronic parenteral feeding
- Patient has daily persistent severe vomiting
- Patient has pronounced dehydration
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 25 mg25 mg | Drug | Cohort 1 Period 1, Cohort 1 Period 2, Cohort 1 Period 3 |
| Placeboplacebo comparator | Drug | Cohort 1 Period 1, Cohort 1 Period 2, Cohort 1 Period 3 |
| GSK962040 50 mg50 mg | Drug | Cohort 1 Period 1, Cohort 1 Period 2, Cohort 1 Period 3 |
| GSK962040 1250 mg125 mg | Drug | Cohort 1 Period 1, Cohort 1 Period 2, Cohort 1 Period 3 |
Primary outcome
Gastric emptying, as measured by the 13C octanoic acid breath test (Gastric half emptying time (t1/2b), Duration of the lag time (tlag), Gastric evacuation coefficient (GEC))
Time frame: 1.5 h post dose to 5.5 h post dose
Safety and tolerability of GSK962040 (Change from baseline and number of patients outside the normal range for blood pressure, heart rate, 12-lead ECG parameters)
Time frame: 2 h post dose
Pharmacokinetic parameters of GSK962040: Cmax, Tmax, AUC(0-t), AUC(0-inf) for single-dose, CL/F, V/F, and, if possible, half-life
Time frame: 24 h post dose
Safety and tolerability of GSK962040 (Adverse events)
Time frame: 6 weeks
Safety and tolerability of GSK962040 (Change from baseline in clinical chemistry and hematology parameters)
Time frame: 24 h post dose
4 secondary outcomes
Bowel movement parameters (Time to first bowel movement after first dose, Bowel movement count, Stool consistency (Bristol Stool Form scale))
Time frame: 24 h post dose
PK/PD relationship of PP, plasma glucagon, GLP-1, and ghrelin after a single dose of GSK962040.
Time frame: 0-6 h post dose
Plasma glucose
Time frame: 24 h post dose
Food intake
Time frame: 24 h post dose
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 26924243Hellstrom PM, Tack J, Johnson LV, Hacquoil K, Barton ME, Richards DB, Alpers DH, Sanger GJ, Dukes GE. The pharmacodynamics, safety and pharmacokinetics of single doses of the motilin agonist, camicinal, in type 1 diabetes mellitus with slow gastric emptying. Br J Pharmacol. 2016 Jun;173(11):1768-77. doi: 10.1111/bph.13475. Epub 2016 Apr 13.
- 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
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GSK962040 25 mg, GSK962040 50 mg and GSK962040 1250 mg in people with Gastroparesis, run by GlaxoSmithKline at 2 sites in 2 countries.
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 16 inclusion and 21 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 2 sites in Belgium, Sweden. 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, as measured by the 13C octanoic acid breath test (Gastric half emptying time (t1/2b), Duration of the lag time (tlag), Gastric evacuation coefficient (GEC)) (time frame: 1.5 h post dose to 5.5 h post dose). The study lists 5 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 NCT00861809, 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.