Gastric MotilityPhase 1NCT02466711
Effect of Relamorelin on Satiation, Gastric Volume, Gastric Accommodation and Distal Gastric Function in Healthy Volunteers
A Phase 1 study testing Relamorelin in people with Gastric Motility, run by Motus Therapeutics, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effects of relamorelin (RM-131) on gastric volume, motor and sensory effects in healthy patients. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Motility
- What is being tested?
- Relamorelin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Sep 2015
- Phase
- Phase 1
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to provide written informed consent prior to any study procedures, and be willing and able to comply with study procedures
- No medical problems or chronic diseases, specifically, no type 2 diabetes mellitus
- Body mass index of 18-35 kg/m²
- Female subjects must have negative urine pregnancy tests and must not be lactating prior to receiving study medication and radiation exposure. For females able to bear children, a hormonal (i.e., oral, implantable, or injectable) and single-barrier method, or a double-barrier method of birth control must be used throughout the study. Female subjects unable to bear children must have this documented in the medical record (i.e., tubal ligation, hysterectomy, or post-menopausal [defined as a minimum of one year since the last menstrual period]).
Who cannot join
- Unable or unwilling to provide informed consent or to comply with study procedures
- Diagnosis of gastrointestinal diseases
- Structural or metabolic diseases that affect the GI system
- Unable to avoid the following over- the- counter medications 48 hours prior to the baseline period and throughout the study:
- Medications that alter GI transit including laxatives, magnesium and aluminum containing antacids, prokinetics, erythromycin,
- Analgesic drugs including NSAIDs and COX-2 inhibitors NOTE: stable doses of thyroid replacement, estrogen replacement, low-dose aspirin for cardioprotection, and birth control (but with adequate backup contraception as drug-interactions with birth control have not been conducted) are permissible.
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- History of recent surgery (within 60 days of screening)
- Acute or chronic illness or history of illness, which in the opinion of the Investigator, could pose a threat or harm to the subject or obscure interpretation of laboratory test results or interpretation of study data such as frequent angina, Class III or IV congestive heart failure, moderate impairment of renal or hepatic function, poorly controlled diabetes, etc.
- Any clinically significant abnormalities on physical examination or laboratory abnormalities identified in the medical record, as determined by the Investigator
- Acute GI illness within 48 hours of initiation of the baseline period
- Females who are pregnant or breastfeeding
- History of excessive alcohol use or substance abuse
- Participation in an investigational study within the 30 days prior to dosing in the present study
- Any other reason, which in the opinion of the Investigator, would confound proper interpretation of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Placebo-controlled, Double-blind Study to Evaluate the Effect of Relamorelin on Satiation, Gastric Volume, Gastric Accommodation and Distal Gastric Function in Healthy Volunteers
The purpose of this study is to evaluate the effects of relamorelin (RM-131) on gastric volume, motor and sensory effects in healthy patients.
- Conditions
- Gastric Motility
- Being tested
- Relamorelin, Placebo
- Keywords
- gastric motility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RelamorelinDrug
Also called RM-131
Double blind RM-131 will be delivered three times by injection during the course of the study
PlaceboDrug
Double blind Placebo will be delivered three times by injection during the course of the study
| Study group | Role | What they receive |
|---|---|---|
| Relamorelin | Active comparator | Not described Receives: Drug: Relamorelin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric volume measured by single photon emission computed tomography (SPECT)
Calculation of gastric volume by single photon emission computed tomography (SPECT)
Measured: Measured during the 1 hour study procedure
Satiety measured by the Hunger/Satiety questionnaire
Measurement of satiety by completion of the Hunger/Satiety questionnaire after ingesting a nutrient drink
Measured: Measured during a 1 hour study procedure
Gastric motility measured by gastroduodenal manometry
Measurement of gastric motility by gastroduodenal manometry
Measured: Measured during the 4 hour study procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionAug 2015
- Study completionSep 2015
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 Gastric MotilityStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Motus Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic
- Responsible party
- Sponsor
- Investigators
- Michael Camilleri, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02466711
- Sponsor's protocol ID
- RM-131-010
- Status last verified
- Sep 2016
- First submitted
- 5 Jun 2015
- Last updated
- 22 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Nelson AD, Camilleri M, Acosta A, Busciglio I, Linker Nord S, Boldingh A, Rhoten D, Ryks M, Burton D. Effects of ghrelin receptor agonist, relamorelin, on gastric motor functions and satiation in healthy volunteers. Neurogastroenterol Motil. 2016 Nov;28(11):1705-1713. doi: 10.1111/nmo.12870. Epub 2016 Jun 9.
PubMed 27283792
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Placebo-controlled, Double-blind Study to Evaluate the Effect of Relamorelin on Satiation, Gastric Volume, Gastric Accommodation and Distal Gastric Function in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02466711
- Acronym / sponsor ID
- RM-131-010
- Conditions
- Gastric Motility
- Keywords
- gastric motility
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Motus Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic
- Study start
- Jun 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 9 Jun 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.
The purpose of this study is to evaluate the effects of relamorelin (RM-131) on gastric volume, motor and sensory effects in healthy patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Relamorelin | Active comparator | Drug: Relamorelin |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Able to provide written informed consent prior to any study procedures, and be willing and able to comply with study procedures
- No medical problems or chronic diseases, specifically, no type 2 diabetes mellitus
- Body mass index of 18-35 kg/m²
- Female subjects must have negative urine pregnancy tests and must not be lactating prior to receiving study medication and radiation exposure. For females able to bear children, a hormonal (i.e., oral, implantable, or injectable) and single-barrier method, or a double-barrier method of birth control must be used throughout the study. Female subjects unable to bear children must have this documented in the medical record (i.e., tubal ligation, hysterectomy, or post-menopausal [defined as a minimum of one year since the last menstrual period]).
Key exclusion criteria (14 listed)
- Unable or unwilling to provide informed consent or to comply with study procedures
- Diagnosis of gastrointestinal diseases
- Structural or metabolic diseases that affect the GI system
- Unable to avoid the following over- the- counter medications 48 hours prior to the baseline period and throughout the study:
- History of recent surgery (within 60 days of screening)
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 |
|---|---|---|
| RelamorelinAlso: RM-131Double blind RM-131 will be delivered three times by injection during the course of the study | Drug | Relamorelin |
| PlaceboDouble blind Placebo will be delivered three times by injection during the course of the study | Drug | Placebo |
Primary outcome
Gastric volume measured by single photon emission computed tomography (SPECT)
Time frame: Measured during the 1 hour study procedure
Calculation of gastric volume by single photon emission computed tomography (SPECT)
Satiety measured by the Hunger/Satiety questionnaire
Time frame: Measured during a 1 hour study procedure
Measurement of satiety by completion of the Hunger/Satiety questionnaire after ingesting a nutrient drink
Gastric motility measured by gastroduodenal manometry
Time frame: Measured during the 4 hour study procedure
Measurement of gastric motility by gastroduodenal manometry
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 22 Sep 2016.
- Derived from this study: PubMed 27283792Nelson AD, Camilleri M, Acosta A, Busciglio I, Linker Nord S, Boldingh A, Rhoten D, Ryks M, Burton D. Effects of ghrelin receptor agonist, relamorelin, on gastric motor functions and satiation in healthy volunteers. Neurogastroenterol Motil. 2016 Nov;28(11):1705-1713. doi: 10.1111/nmo.12870. Epub 2016 Jun 9.
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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.
Michael Camilleri, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Relamorelin in people with Gastric Motility, run by Motus Therapeutics, Inc. at 1 site in United States.
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 4 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: finished, as of the sponsor's last update on 22 Sep 2016. 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 United States. 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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 volume measured by single photon emission computed tomography (SPECT) (time frame: Measured during the 1 hour study procedure). 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 NCT02466711, 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 22 Sep 2016.