DRUG
RM-131
Double blind RM-131 (100 ug) will be delivered once by injection during study procedure.
Status
Completed
Phase
Phase 1
Enrollment
18
Locations
1
Results
Not posted
Publications
0
Study 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.
Interventions
DRUG
Double blind RM-131 (100 ug) will be delivered once by injection during study procedure.
DRUG
Double blind placebo will be delivered once by injection during study procedure.
Timeline
First posted
May 14, 2014
Study start
Aug 2014
Primary completion
Nov 2014
Study completion
Nov 2014
Results posted
Not reported
Registry updated
Sep 22, 2016
Outcomes
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
Not reported in the indexed record.
Eligibility
Inclusion Criteria: 1. Able to provide written informed consent prior to any study procedures, and be willing and able to comply with study procedures. 2. 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 3. Stable concomitant medications defined as no changes in regimen for at least 2 weeks prior to the study period. 4. Body mass index of 18-40 kg/m2 5. 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 \[defined as a minimum of one year since the last menstrual period\]). Exclusion Criteria: 1. Unable or unwilling to provide informed consent or to comply with study procedures 2. Diagnosis of secondary constipation e.g. underlying general neurological disease such as Parkinsonism, multiple sclerosis, diseases associated with peripheral neuropathy, iatrogenic constipation 3. 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 4. 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 * 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 5. History of recent surgery (within 60 days of screening) 6. 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. 7. Any clinically significant abnormalities on physical examination or laboratory abnormalities identified in the medical record, as determined by the Investigator 8. Acute GI illness within 48 hours of initiation of the colonic study day 9. Females who are pregnant or breastfeeding 10. History of alcohol or substance abuse; Alcohol use 2 days before colonic study day 11. Participation in a clinical study involving an investigational medication within the 30 days prior to dosing in the present study 12. Any other reason, which in the opinion of the Investigator, would confound proper interpretation of the study
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Publications
No PMID-linked publications were present in this registry snapshot.
Related trials
Allergan · Gastroparesis · Diabetes Mellitus
Phase 3
Terminated
467
2021-12
Allergan · Gastroparesis
Phase 3
Terminated
202
2021-12
Allergan · Gastroparesis · Diabetes Mellitus
Phase 3
Terminated
450
2021-11
Allergan · Gastroparesis · Diabetes Mellitus
Phase 3
Terminated
311
2021-08
Allergan · Gastroparesis · Diabetes Mellitus
Phase 3
Terminated
336
2021-07
Allergan · Diabetes Mellitus · Diabetes Mellitus Complications
Phase 2
Completed
393
2019-07
Motus Therapeutics, Inc. · Diabetes Mellitus · Diabetes Mellitus Complications
Phase 2
Completed
204
2016-09
Motus Therapeutics, Inc. · Anorexia Nervosa
Phase 2
Completed
20
2016-09
Related PeptideStat pages
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.