Phase 2 Study to Evaluate Safety and Efficacy of RM-131 Administered to Patients With Chronic Constipation

NCT01781104 | Completed Phase 2

• 1 other identifier: RM-131-006
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Constipation

Keywords

constipation gastric emptying gastrointestinal motility ghrelin

Outcome Measures

Primary Outcomes (1)

• Effect of RM-131 on colonic transit

  Change from baseline colonic geometric center at 24 hours

  End of 14 day Baseline and end of 14 day Treatment periods

Secondary Outcomes (2)

• Safety and tolerability of RM-131

  Duration of the study, an expected average of 9 weeks

• Effect of RM-131 on stool consistency

  Daily for the duration of the study, an expected average of 9 weeks

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 subcutaneously once daily for 14 days.

RM-131

Placebo DRUG

Placebo delivered subcutaneously once daily for 14 days.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 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 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Motus Therapeutics, Inc.: lead

Study Sites (3)

Mayo Clinic Arizona

Scottsdale, Arizona, United States

Location

Mayo Clinic Florida

Jacksonville, Florida, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, United States

Location

Related Publications (2)

• 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.

  PMID: 26467700 DERIVED

• Acosta 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.

  PMID: 26001337 DERIVED

MeSH Terms

Conditions

Constipation

Interventions

relamorelin

Condition Hierarchy (Ancestors)

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

Study Officials

• Elizabeth Stoner, MD

  Rhythm Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2013
• First Posted: January 31, 2013
• Study Start: March 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: October 1, 2014
• Last Updated: September 23, 2016

Record last verified: 2016-09

Locations

US (3)