Study to Evaluate the Effects of RM-131 in Patients With Chronic Constipation

NCT02137642 | Completed Phase 1

• 1 other identifier: RM-131-008
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Constipation

Keywords

constipation

Outcome Measures

Primary Outcomes (1)

• Effect of RM-131 on postprandial high amplitude propagated contractions (HAPC) per hour

  Change from baseline HAPC

  Measured during the 2 hour study procedure

Study Arms (2)

RM-131

ACTIVE COMPARATOR

Drug: RM-131

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

RM-131 DRUG

Double blind RM-131 (100 ug) will be delivered once by injection during study procedure.

Also known as: relamorelin

RM-131

Placebo DRUG

Double blind placebo will be delivered once by injection during study procedure.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[defined as a minimum of one year since the last menstrual period\]).

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Motus Therapeutics, Inc.: lead
• Mayo Clinic: collaborator

Study Sites (1)

Mayo Clinic - Rochester

Rochester, Minnesota, United States

Location

MeSH Terms

Conditions

Constipation

Interventions

relamorelin

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Camilleri, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2014
• First Posted: May 14, 2014
• Study Start: August 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: September 22, 2016

Record last verified: 2016-09

Locations

US (1)