12 Week Efficacy and Safety Trial Followed by a 4 Week Withdrawal Period for Patients With Chronic Idiopathic Constipation (Echo 2)

This study has been terminated.
(Terminated due to a distribution issue with the trial medication)
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01833065
First received: April 12, 2013
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

12 Week Efficacy and Safety Trial Followed by a 4 Week Withdrawal Period for Patients with Chronic Idiopathic Constipation.


Condition Intervention Phase
Chronic Idiopathic Constipation
Drug: Elobixibat 10 mg
Drug: Elobixibat 5 mg
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Overall Complete Spontaneous Bowel Movement (CSBM) Response [ Time Frame: At 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of CSBM Response [ Time Frame: Within 24 hours of treatment initiation ] [ Designated as safety issue: No ]
  • Change from Baseline in weekly frequency of Spontaneous Bowel Movement (SBMs) [ Time Frame: For the overall 12-week Treatment Period ] [ Designated as safety issue: No ]
  • Change from Baseline in weekly stool consistency of SBMs [ Time Frame: For the overall 12-week Treatment Period ] [ Designated as safety issue: No ]
  • Total Patient Assessment of Constipation - Quality of Life (PAC-QOL) score responder [ Time Frame: At Week 12 ] [ Designated as safety issue: No ]
  • Change from Baseline in weekly degree of straining of SBMs [ Time Frame: For the overall 12-week Treatment Period ] [ Designated as safety issue: No ]
  • Change from Baseline in weekly abdominal bloating score [ Time Frame: For the overall 12-weekTreatment Period ] [ Designated as safety issue: No ]
  • Change from Baseline in weekly abdominal discomfort score [ Time Frame: For the overall 12-week Treatment Period ] [ Designated as safety issue: No ]

Enrollment: 314
Study Start Date: April 2013
Study Completion Date: April 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Elobixibat 10 mg Drug: Elobixibat 10 mg
Experimental: Elobixibat 5 mg Drug: Elobixibat 5 mg
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Body mass index (BMI) ≥18.5 but <35.0
  • Male or female ≥18 years of age
  • Reports <3 spontaneous Bowel Movements (BM) per week and reports one or more of the following symptoms for the last 3 months with symptom onset at least 6 months before the Screening Visit or before starting chronic therapy with any laxative:

    1. Straining during at least 25% of defecations
    2. Lumpy or hard stools during at least 25% of defecations
    3. Sensation of incomplete evacuation during at least 25% of defecations
  • Is ambulatory
  • An initial colonoscopy is required if recommended by national guidelines

Exclusion Criteria:

  • Reports loose (mushy) or watery stools in the absence of any laxative intake in the form of a tablet, a suppository or an enema, or prohibited medicine for >25% of BMs
  • The patient reports a Bristol Stool Form Scale (BSFS) of 6 or 7 during the Pretreatment Period
  • Has irritable bowel syndrome (IBS) with pain/discomfort as predominant symptoms
  • Has a structural abnormality of the Gastrointestinal (GI) tract or a disease or condition that can affect GI motility
  • Has a history of diverticulitis, chronic pancreatitis, active peptic ulcer disease (PUD) not adequately treated, ischaemic colitis, inflammatory bowel disease, laxative abuse, faecal impaction that required hospitalization or emergency treatment, pseudo-obstruction, megacolon, megarectum, bowel obstruction, descending perineum syndrome, ovarian cysts, endometriosis, solitary rectal ulcer syndrome, systemic sclerosis, pre-malignant colonic disease (e.g., familial adenomatous polyposis or hereditary non-polyposis colorectal cancer) or other forms of familial colorectal cancer
  • Has unexplained and clinically significant GI alarm signals (e.g., lower GI bleeding or heme-positive stool in the absence of known internal or external haemorrhoids, iron-deficiency anaemia, unexplained weight loss) or systemic signs of infection or colitis
  • Has a potential central nervous system (CNS) cause of constipation (e.g., Parkinson's disease, spinal cord injury, multiple sclerosis)
  • Has intestinal/rectal prolapse or other known pelvic floor dysfunction
  • Commonly uses digital maneuvers (perianal pressure or digital disimpaction) or vaginal splinting to facilitate the passage of a bowel movement
  • Has a history of diabetic neuropathy
  • Has a history of bariatric surgery for treatment of obesity; surgery to remove a segment of the GI tract; or surgery of the abdomen, pelvic or retroperitoneal area during the 6 months prior to Screening; or appendectomy or cholecystectomy 3 months prior to screening; or other major surgery 1 month prior to Screening
  • Has a history of cancer with last date of proven disease activity/presence of malignancy within 5 years, except for adequately treated basal cell carcinoma of the skin, cervical dysplasia, or carcinoma in situ of the skin or the cervix
  • Known human immunodeficiency virus (HIV) or Hepatitis B/C (HBV/HCV) infection
  • Has a history of hospitalization for any psychiatric disorder, or any suicide attempt in the 2 years prior to Screening
  • Is actively abusing alcohol or drugs or has a history of alcohol or drug abuse during the 6 months prior to Screening
  • Is being treated for hypothyroidism, but the dose of medication has not been stable for at least 3 months at the time of Screening
  • is a pregnant, breast-feeding, or lactating woman
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01833065

  Show 97 Study Locations
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01833065     History of Changes
Other Study ID Numbers: 000080, 2012-005588-28
Study First Received: April 12, 2013
Last Updated: April 28, 2014
Health Authority: Brazil: National Health Surveillance Agency
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Mexico: Federal Commission for Sanitary Risks Protection
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Constipation
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 21, 2014