Chronic ConstipationPhase 1NCT02137642
Study to Evaluate the Effects of RM-131 in Patients With Chronic Constipation
A Phase 1 study testing RM-131 in people with Chronic Constipation, run by Motus Therapeutics, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate safety and tolerability as well as the effects of RM-131 on colonic motor and sensory effects in patients with chronic constipation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Constipation
- What is being tested?
- RM-131
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Nov 2014
- 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
- No healthy volunteers
- 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.
- Subjects with chronic IDIOPATHIC constipation, including experiencing constipation for 12 or more weeks in the preceding 12 months. Chronic constipation is to be defined by the Rome III criteria for Functional Constipation
- Stable concomitant medications defined as no changes in regimen for at least 2 weeks prior to the study period.
- Body mass index of 18-40 kg/m2
- Female patients must have negative urine pregnancy tests and must not be lactating. 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 patients unable to bear children must have this documented in their medical history. (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 secondary constipation e.g. underlying general neurological disease such as Parkinsonism, multiple sclerosis, diseases associated with peripheral neuropathy, iatrogenic constipation
- Structural or metabolic diseases that affect the GI system NOTE: Patients with clinical suspicion of upper or lower GI obstruction must have been evaluated per standard of care and obstruction ruled out before screening
- Unable to withdraw the following medications 48 hours prior to the colon study day and throughout the study:
- Medications that alter GI transit including laxatives, magnesium and aluminum containing antacids, prokinetics, erythromycin, narcotics, aspirin, anti-cholinergics, tricyclic antidepressants, SNRI and newer antidepressants. With the exception of GoLYTELY which will be taken the evening prior to colon study day. 4- Selective serotonin reuptake inhibitor (SSRI) antidepressants are permissible at low, stable doses. All medications shall be reviewed and dis/approved by the principal investigator on a case by case basis.
- Analgesic drugs including opiates, NSAIDs and COX-2 inhibitors
Show all 17Show fewer
- GABAnergic agents
- Benzodiazepines NOTE: stable doses of thyroid replacement, estrogen replacement and birth control (but with adequate backup contraception as drug-interactions with birth control have not been conducted) are permissible.
- Drugs with a low therapeutic index, such as warfarin, digoxin, anti-seizure medications
- 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 patient 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 colonic study day
- Females who are pregnant or breastfeeding
- History of alcohol or substance abuse; Alcohol use 2 days before colonic study day
- Participation in a clinical study involving an investigational medication 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 Effects of RM-131 on Colonic Motor Functions in Patients With Chronic Constipation
The purpose of this study is to evaluate safety and tolerability as well as the effects of RM-131 on colonic motor and sensory effects in patients with chronic constipation.
- Conditions
- Chronic Constipation
- Being tested
- RM-131, Placebo
- Keywords
- constipation
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RM-131Drug
Also called relamorelin
Double blind RM-131 (100 ug) will be delivered once by injection during study procedure.
PlaceboDrug
Double blind placebo will be delivered once by injection during study procedure.
| Study group | Role | What they receive |
|---|---|---|
| RM-131 | Active comparator | Not described Receives: Drug: RM-131 |
| 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.
Effect of RM-131 on postprandial high amplitude propagated contractions (HAPC) per hour
Change from baseline HAPC
Measured: Measured during the 2 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 posted14 May 2014 (estimated)
- Study startAug 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic ConstipationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 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
- NCT02137642
- Sponsor's protocol ID
- RM-131-008
- Status last verified
- Sep 2016
- First submitted
- 12 May 2014
- Last updated
- 22 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
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 Effects of RM-131 on Colonic Motor Functions in Patients With Chronic Constipation
- ClinicalTrials.gov ID
- NCT02137642
- Acronym / sponsor ID
- RM-131-008
- Conditions
- Chronic Constipation
- Keywords
- constipation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Motus Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic
- Study start
- Aug 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 14 May 2014 (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 safety and tolerability as well as the effects of RM-131 on colonic motor and sensory effects in patients with chronic constipation.
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 |
|---|---|---|
| RM-131 | Active comparator | Drug: RM-131 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able to provide written informed consent prior to any study procedures, and be willing and able to comply with study procedures.
- Subjects with chronic IDIOPATHIC constipation, including experiencing constipation for 12 or more weeks in the preceding 12 months. Chronic constipation is to be defined by the Rome III criteria for Functional Constipation
- Stable concomitant medications defined as no changes in regimen for at least 2 weeks prior to the study period.
- Body mass index of 18-40 kg/m2
- Female patients must have negative urine pregnancy tests and must not be lactating. 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 patients unable to bear children must have this documented in their medical history. (i.e., tubal ligation, hysterectomy, or post-menopausal [defined as a minimum of one year since the last menstrual period]).
Key exclusion criteria (17 listed)
- Unable or unwilling to provide informed consent or to comply with study procedures
- Diagnosis of secondary constipation e.g. underlying general neurological disease such as Parkinsonism, multiple sclerosis, diseases associated with peripheral neuropathy, iatrogenic constipation
- Structural or metabolic diseases that affect the GI system NOTE: Patients with clinical suspicion of upper or lower GI obstruction must have been evaluated per standard of care and obstruction ruled out before screening
- Unable to withdraw the following medications 48 hours prior to the colon study day 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 |
|---|---|---|
| RM-131Also: relamorelinDouble blind RM-131 (100 ug) will be delivered once by injection during study procedure. | Drug | RM-131 |
| PlaceboDouble blind placebo will be delivered once by injection during study procedure. | Drug | Placebo |
Primary outcome
Effect of RM-131 on postprandial high amplitude propagated contractions (HAPC) per hour
Time frame: Measured during the 2 hour study procedure
Change from baseline HAPC
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.
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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 RM-131 in people with Chronic Constipation, 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 5 inclusion and 17 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?
Effect of RM-131 on postprandial high amplitude propagated contractions (HAPC) per hour (time frame: Measured during the 2 hour study procedure). 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 22 Sep 2016.