Efficacy of Linaclotide to Senna for CIC

NCT02239510 | Terminated Results

• 1 other identifier: 14040
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

In this prospective, randomized, double blind study, the aim is to determine the efficacy of Linaclotide in relation to Senna in relieving the symptoms of chronic idiopathic constipation (CIC). Patients with CIC, (age 18 - 70) will be enrolled in the study and randomized to Senna or Linaclotide. Patients will be asked to complete questionnaires during the study and will be followed for 12 weeks. Main outcomes include number of daily bowel movements and measures from surveys regarding bowel habits, relief, and satisfaction.

Conditions

Chronic Idiopathic Constipation

Keywords

constipation; bowel habits

Outcome Measures

Primary Outcomes (1)

• Change in Number of Bowel Movements Per Week

  Change from before to after in number of weekly bowel movements

  12 weeks

Secondary Outcomes (3)

• Number of Participants With Relief

  12 weeks

• Change in Assessment of Bowel Habit

  12 weeks

• Change in Satisfaction With Bowel Habit

  12 weeks

Study Arms (2)

Senna

ACTIVE COMPARATOR

1 capsule (50 mg) Senna daily for 12 weeks

Drug: Senna

Linzess

ACTIVE COMPARATOR

1 capsule (145 mcg) once daily for 12 weeks

Drug: Linzess

Interventions

Senna DRUG

1 capsule (50 mg) Senna daily for 12 weeks

Also known as: sennoside

Senna

Linzess DRUG

1 capsule (145 mcg) of Linzess once daily for 12 weeks

Also known as: Linaclotide

Linzess

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females 18 - 70 years of age. Diagnosed with CIC according to Rome III criteria. Coherent and mentally competent patient to understand and consent for the trial Unremarkable colonoscopy done in past 5 years

You may not qualify if:

• Significant diarrhea (defined as loose or watery stool and or more than three bowel movements daily associated with urgency more than 25% of the days in preceding 3 months) Untreated hypothyroidism Organic or structural disease as the cause of patient's symptoms (stricture or tumor) Diseases that affect bowel transit time (Gastroparesis, short bowel syndrome) Evidence of cathartic colon History of alcohol, laxative abuse or illicit drug use Pregnant or lactating women Planning pregnancy or become pregnant during study period Concomitant use of any medication that could alter gastrointestinal motility (Calcium channel blockers, Narcotics, anticholinergics, calcium and aluminium containing antacids, phenothiazines, ferrous sulfate)

Sponsors & Collaborators

• TriHealth Inc.: lead

Study Sites (1)

TriHealth

Cincinnati, Ohio, 45220, United States

Location

MeSH Terms

Conditions

Constipation

Interventions

Sennosides; linaclotide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Senna Extract; Anthraquinones; Anthrones; Anthracenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Quinones; Polycyclic Compounds; Glycosides; Carbohydrates; Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Jenni Steinbrunner
• Organization: TriHealth Hatton Research Institute

jenni_steinbrunner@trihealth.com

513-862-4033

Study Officials

• Mohd A AlSamman, MD

  TriHealth Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2014
• First Posted: September 12, 2014
• Study Start: September 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: July 2, 2019
• Results First Posted: July 2, 2019

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)