ConstipationPhase 2NCT01781104
Phase 2 Study to Evaluate Safety and Efficacy of RM-131 Administered to Patients With Chronic Constipation
A Phase 2 study testing RM-131 in people with Constipation, run by Motus Therapeutics, Inc. at 3 sites 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 transit, bowel consistency, bowel habits, abdominal pain, and other abdominal symptoms in patients with chronic constipation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- 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
- 48 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2013to Oct 2014
- 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 75 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 willing and able to comply with study procedures.
- Diagnosis of chronic IDIOPATHIC constipation, including experiencing constipation for 12 or more weeks in the preceding 12 months (defined by Rome III criteria for Functional Constipation, but all patients must meet the modified criterion of a history of ≤4 average defecations per week)
- Stable concomitant medications (no changes in regimen for at least 2 weeks prior to baseline period)
- Body mass index of 18-40 kg/m2
- Females must not be lactating or pregnant
Who cannot join
- Unable/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 baseline period and throughout the study (except as protocol defined rescue medications):
- Medications that alter GI transit including laxatives, magnesium and aluminum containing antacids, prokinetics, erythromycin, narcotics, anti-cholinergics, tricyclic antidepressants, SNRI and newer antidepressants
- Selective serotonin reuptake inhibitor (SSRI) antidepressants are permissible at low, stable doses
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- Analgesic drugs including opiates, NSAIDs and COX-2 inhibitors
- GABAnergic agents
- Benzodiazepines
- 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
- Drugs with a low therapeutic index, such as warfarin, digoxin, anti-seizure medications
- History of surgery within 60 days of screening
- Acute or chronic illness or history of illness, which in the opinion of Investigator, could pose threat/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
- History of hypersensitivity to mannitol (an ingredient of both active and placebo study medications)
- Clinically significant abnormalities on screening laboratories or physical examination as determined by Investigator
- Abnormal 12-lead electrocardiogram (ECG), including evidence of acute myocardial or subendocardial ischemia and clinically significant arrhythmias or conduction abnormalities (including prolonged QTc > 500 msec) or abnormal blood pressure at screening except minor deviations deemed to be of no clinical significance by Investigator
- Acute GI illness within 48 hours of initiation of the baseline period
- ALT or AST > 1.2 X upper limit of normal during screening
- Females who are pregnant or breastfeeding
- History of excessive alcohol use or substance abuse
- Participation in an investigational clinical study within 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
- In addition, patients will not be randomized into the double-blind treatment comparison if during the baseline period they:
- used rescue medications such as laxatives, beyond those allowed by protocol
- demonstrated lack of compliance
- averaged more than 4 spontaneous bowel movements per week
- Substudy patients only: did not demonstrate slow colonic transit at end of baseline period (GC 24 >2.4)
- Women of child-bearing potential: positive pregnancy test
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mayo Clinic Florida
Jacksonville, Florida
Mayo Clinic Rochester
Rochester, Minnesota
Mayo Clinic Arizona
Scottsdale, Arizona
About this study
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Multiple Dose, Parallel Group Study to Evaluate the Efficacy, Safety, and Pharmacodynamics of RM-131 Administered to 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 transit, bowel consistency, bowel habits, abdominal pain, and other abdominal symptoms in patients with chronic constipation.
- Conditions
- Constipation
- Being tested
- RM-131, Placebo
- Keywords
- constipation gastric emptying gastrointestinal motility ghrelin
- 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
Double blind RM-131 (100 ug) will be delivered subcutaneously once daily for 14 days.
PlaceboDrug
Placebo delivered subcutaneously once daily for 14 days.
| 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 colonic transit
Change from baseline colonic geometric center at 24 hours
Measured: End of 14 day Baseline and end of 14 day Treatment periods
Secondary outcomes (2)
Safety and tolerability of RM-131
Assessment of adverse events and clinical laboratory evaluations
Measured: Duration of the study, an expected average of 9 weeks
Effect of RM-131 on stool consistency
Change in responses on Bowel Habit Diary Cards
Measured: Daily for the duration of the study, an expected average of 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2013 (estimated)
- Study startMar 2013
- Primary completionSep 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Motus Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elizabeth Stoner, MD, Study director, Rhythm Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01781104
- Sponsor's protocol ID
- RM-131-006
- Status last verified
- Sep 2016
- First submitted
- 28 Jan 2013
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Acosta A, Camilleri M, Busciglio I, Boldingh A, Nelson AD, Burton D. Short-Term Effects of Relamorelin on Descending Colon Motility in Chronic Constipation: A Randomized, Controlled Trial. Dig Dis Sci. 2016 Mar;61(3):852-60. doi: 10.1007/s10620-015-3876-5. Epub 2015 Oct 14.
PubMed 26467700Acosta A, Camilleri M, Kolar G, Iturrino J, Szarka LA, Boldingh A, Burton D, Ryks M, Rhoten D, Zinsmeister AR, Spence SC, Gottesdiener K, Bouras EP, Vazquez-Roque MI. Relamorelin Relieves Constipation and Accelerates Colonic Transit in a Phase 2, Placebo-Controlled, Randomized Trial. Clin Gastroenterol Hepatol. 2015 Dec;13(13):2312-9.e1. doi: 10.1016/j.cgh.2015.04.184. Epub 2015 May 19.
PubMed 26001337
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-blind, Placebo-controlled, Multiple Dose, Parallel Group Study to Evaluate the Efficacy, Safety, and Pharmacodynamics of RM-131 Administered to Patients With Chronic Constipation
- ClinicalTrials.gov ID
- NCT01781104
- Acronym / sponsor ID
- RM-131-006
- Conditions
- Constipation
- Keywords
- constipation gastric emptying gastrointestinal motility ghrelin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Motus Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 31 Jan 2013 (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 transit, bowel consistency, bowel habits, abdominal pain, and other abdominal symptoms in patients with chronic constipation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- 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 75 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 willing and able to comply with study procedures.
- Diagnosis of chronic IDIOPATHIC constipation, including experiencing constipation for 12 or more weeks in the preceding 12 months (defined by Rome III criteria for Functional Constipation, but all patients must meet the modified criterion of a history of ≤4 average defecations per week)
- Stable concomitant medications (no changes in regimen for at least 2 weeks prior to baseline period)
- Body mass index of 18-40 kg/m2
- Females must not be lactating or pregnant
Key exclusion criteria (28 listed)
- Unable/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 baseline period and throughout the study (except as protocol defined rescue medications):
- 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
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-131Double blind RM-131 (100 ug) will be delivered subcutaneously once daily for 14 days. | Drug | RM-131 |
| PlaceboPlacebo delivered subcutaneously once daily for 14 days. | Drug | Placebo |
Primary outcome
Effect of RM-131 on colonic transit
Time frame: End of 14 day Baseline and end of 14 day Treatment periods
Change from baseline colonic geometric center at 24 hours
2 secondary outcomes
Safety and tolerability of RM-131
Time frame: Duration of the study, an expected average of 9 weeks
Effect of RM-131 on stool consistency
Time frame: Daily for the duration of the study, an expected average of 9 weeks
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 23 Sep 2016.
- Derived from this study: PubMed 26467700Acosta A, Camilleri M, Busciglio I, Boldingh A, Nelson AD, Burton D. Short-Term Effects of Relamorelin on Descending Colon Motility in Chronic Constipation: A Randomized, Controlled Trial. Dig Dis Sci. 2016 Mar;61(3):852-60. doi: 10.1007/s10620-015-3876-5. Epub 2015 Oct 14.
- Derived from this study: PubMed 26001337Acosta A, Camilleri M, Kolar G, Iturrino J, Szarka LA, Boldingh A, Burton D, Ryks M, Rhoten D, Zinsmeister AR, Spence SC, Gottesdiener K, Bouras EP, Vazquez-Roque MI. Relamorelin Relieves Constipation and Accelerates Colonic Transit in a Phase 2, Placebo-Controlled, Randomized Trial. Clin Gastroenterol Hepatol. 2015 Dec;13(13):2312-9.e1. doi: 10.1016/j.cgh.2015.04.184. Epub 2015 May 19.
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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.
Elizabeth Stoner, MD study director
Rhythm Pharmaceuticals, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RM-131 in people with Constipation, run by Motus Therapeutics, Inc. at 3 sites 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 28 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 23 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 3 sites 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 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?
Effect of RM-131 on colonic transit (time frame: End of 14 day Baseline and end of 14 day Treatment periods). 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 NCT01781104, which also lists 2 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 23 Sep 2016.