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Efficacy and Safety Trial of Elobixibat in Patients With Chronic Idiopathic Constipation

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ClinicalTrials.gov Identifier: NCT01833065
Recruitment Status : Terminated (Terminated due to a distribution issue with the trial medication)
First Posted : April 16, 2013
Results First Posted : October 20, 2015
Last Update Posted : October 20, 2015
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Chronic Idiopathic Constipation Drug: Elobixibat 10 mg/day Drug: Elobixibat 5 mg/day Drug: Placebo Phase 3

Detailed Description:

The present trial was designed to determine the efficacy and safety of elobixibat treatment (at both doses of 5 mg and 10 mg/day) compared to placebo treatment for 12-week Treatment Period followed by a 4-week Withdrawal Period in patients with chronic idiopathic constipation. During Withdrawal Period a sub-group of patients in elobixibat 5 mg and 10 mg treatment arms respectively received placebo treatment, while rest of the patients continued with 5 mg and 10 mg treatment in respective groups. In placebo groups, patients received elobixibat 10 mg treatment during Withdrawal Period. Patients were followed-up for 2 weeks after end of the Withdrawal Period.

The assessment of primary and key secondary end points was done for patients who completed the first 12 weeks of treatment period. Incidence of Adverse Events (AEs) were reported till 2 weeks after end of the Withdrawal Period.

The trial was early terminated due to a distribution issue with the trial medication.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 314 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomised, Placebo-controlled, Phase 3 Trial in Patients With Chronic Idiopathic Constipation to Demonstrate the Efficacy and Safety of Elobixibat 5 mg and 10 mg for 12 Weeks Followed by a 4-week Withdrawal Period
Study Start Date : April 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
Experimental: EBX 10
Elobixibat 10 mg/day
Drug: Elobixibat 10 mg/day
Elobixibat 10 mg/day
Other Name: A3309

Experimental: EBX 5
Elobixibat 5 mg/day
Drug: Elobixibat 5 mg/day
Elobixibat 5 mg/day
Other Name: A3309

Placebo Comparator: PLCBO
Placebo
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Overall Complete Spontaneous Bowel Movement (CSBM) Response [ Time Frame: During the first 12 weeks ]
    This outcome measured the percentage of patients who were CSBM responders. A CSBM responder was defined as a patient with ≥3 CSBMs per week and an increase of ≥1 CSBM per week from Baseline, for at least 9 of the 12 weeks in the 12-week Treatment Period, including at least 3 weeks during Weeks 9-12.


Secondary Outcome Measures :
  1. Occurrence of CSBM Response [ Time Frame: Within first 24 hours of treatment initiation ]
    This outcome measured the percentage of patients who had a CSBM within 24 hours after the first dose of treatment. A CSBM was defined as a spontaneous (occurring without laxative within the preceding 24 hours, including no rescue medication within the preceding 24 hours) bowel movement (as interpreted by the patient, with a beginning and an end, including single or multiple stools), accompanied by a patient reported sense of complete evacuation ('complete').

  2. Change From Baseline in Weekly Frequency of Spontaneous Bowel Movement (SBMs) [ Time Frame: From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period ]
    The change from Baseline for the continuous variable was estimated using a repeated measures analysis of covariance (ANCOVA) model.

  3. Change From Baseline in Weekly Stool Consistency of SBMs [ Time Frame: From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period ]

    The stool consistency is measured using the seven-point ordinal Bristol Stool Form Scale (BSFS) score. The BSFS classifies human stool into seven types and points them accordingly.

    Type 1: Separate hard lumps, like nuts (hard to pass) Type 2: Sausage-shaped, but lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage or snake, smooth and soft Type 5: Soft blobs with clear cut edges (passed easily) Type 6: Fluffy pieces with ragged edges, a mushy stool Type 7: Watery, no solid pieces, entirely liquid Types 1 and 2 indicate constipation, with 3 and 4 represents the ideal stool form (especially the latter), and 5, 6 and 7 tends towards diarrhoea .

    For a given assessment week, the weekly stool consistency was defined as the sum of non-missing stool consistency score for SBMs during that week divided by the number of non-missing stool consistency score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model.


  4. Total Patient Assessment of Constipation - Quality of Life (PAC-QOL) Score Responder [ Time Frame: At Week 12 ]

    This outcome measured the percentage of patients who were PAC-QOL score responder at 12-week Treatment Period. A PAC-QOL score responder was defined as a patient with ≥50% reduction in total PAC-QOL score from Baseline at Week 12.

    PAC-QOL is a 28-item questionnaire for psychometric assessment of disease-specific quality of life. The questionnaire is based on 5-point Likert scale; ranging from 0 [none of the time or not at all] to 4 [all of the time or extremely]). A lower score indicates a better Quality of Life. The PAC-QOL questionnaire is developed specifically for patients with constipation.

    Total PAC-QOL score was averaged from the individual item score.


  5. Change From Baseline in Weekly Degree of Straining of SBMs [ Time Frame: From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period ]

    The degree of straining was measured using the five-point ordinal scale (1=Not at all, 2=A little bit, 3=A moderate amount, 4=A great deal, and 5=An extreme amount).

    For a given assessment week, the weekly degree of straining was defined as the sum of non-missing straining score for SBMs during that week divided by the number of non-missing straining score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model.


  6. Change From Baseline in Weekly Abdominal Bloating Score [ Time Frame: From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period ]

    The abdominal pain score was measured using the five-point ordinal scale (1=None, 2=Mild, 3=Moderate, 4=Severe, and 5=Very severe).

    For a given assessment week, the weekly abdominal bloating score was defined as the sum of non-missing abdominal bloating score for SBMs during that week divided by the number of non-missing abdominal bloating score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model.


  7. Change From Baseline in Weekly Abdominal Discomfort Score [ Time Frame: From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period ]

    The abdominal discomfort score was measured using the five-point ordinal scale (1=None, 2=Mild, 3=Moderate, 4=Severe, and 5=Very severe).

    For a given assessment week, the weekly abdominal discomfort score was defined as the sum of non-missing abdominal discomfort score for SBMs during that week divided by the number of non-missing abdominal discomfort score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Body mass index (BMI) ≥18.5 but <35.0 kg/m^2
  • 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 and community dwelling
  • 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01833065


  Hide Study Locations
Locations
United States, Alabama
Birmingham Gastroenterology Associates, PC
Birmingham, Alabama, United States
United States, Arizona
Genova Clinical Research, Inc.
Tucson, Arizona, United States
United States, Arkansas
Preferred Research Partners
Little Rock, Arkansas, United States
Arkansas Gastroenterology
North Little Rock, Arkansas, United States
United States, California
David Geffen School of Medicine at University of California, Los Angeles
Los Angeles, California, United States
West Gastroenterology Associates
Los Angeles, California, United States
Sacramento Research Medical Group
Sacramento, California, United States
Precision Research Institute, LLC
San Diego, California, United States
United States, Connecticut
Gastroenterology Associates of Fairfield County
Bridgeport, Connecticut, United States
United States, Florida
Zasa Clinical Research
Boynton Beach, Florida, United States
Meridien Research
Bradenton, Florida, United States
Sanitas Research
Coral Gables, Florida, United States
Lake Internal Medicine Associates
Eustis, Florida, United States
Health Care Family Rehab Corp.
Hialeah, Florida, United States
Southeast Clinical Research, LLC
Jacksonville, Florida, United States
Health Awareness, Inc.
Jupiter, Florida, United States
United States, Georgia
Mount Vernon Clinical Research
Atlanta, Georgia, United States
Southeast Regional Research Group
Columbus, Georgia, United States
United States, Illinois
Premier Healthcare Research, LLC
Evanston, Illinois, United States
Rockford Gastroenterology Associates, Ltd.
Rockford, Illinois, United States
United States, Kansas
Heartland Research Associates, LLC
Augusta, Kansas, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
Professional Research Network of Kansas, LLC
Witchita, Kansas, United States
United States, Louisiana
Louisiana Research Center, LLC
Shreveport, Louisiana, United States
United States, Massachusetts
Beacon Clinical Research, LLC
Brockton, Massachusetts, United States
United States, Nebraska
Quality Clinical Research, Inc.
Omaha, Nebraska, United States
United States, New York
Long Island Gastrointestinal Research Group
Great Neck, New York, United States
United States, North Carolina
Carolina Digestive Health Associates, PA
Charlotte, North Carolina, United States
Carolina Digestive Health Associates, PA
Concord, North Carolina, United States
PharmQuest, LLC
Greensboro, North Carolina, United States
Peters Medical Research, LLC
High Point, North Carolina, United States
Wake Research Associates, LLC
Raleigh, North Carolina, United States
United States, Ohio
Hometown Urgent Care and Occupational Health
Columbus, Ohio, United States
Hometown Urgent Care and Occupational Health
Dayton, Ohio, United States
Family Practice Center of Wadsworth
Wadsworth, Ohio, United States
United States, Oklahoma
Clinical Research Associates, LLC
Oklahoma City, Oklahoma, United States
United States, Oregon
Sunstone Medical Research, LLC
Medford, Oregon, United States
United States, Pennsylvania
Family Medical Associates
Levittown, Pennsylvania, United States
United States, South Carolina
Anderson Gastroenterology Associates
Anderson, South Carolina, United States
Palmetto Clinical Research
Summerville, South Carolina, United States
United States, Tennessee
Associates in Gastroenterology, LLC
Hermitage, Tennessee, United States
HCCA Clinical Research Solutions
Jackson, Tennessee, United States
New Phase Research and Development, LLC
Knoxville, Tennessee, United States
United States, Texas
Research Across America
Katy, Texas, United States
United States, Virginia
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, United States
Brazil
Fundacao IMEPEM - Universidade Federal de Juiz de Fora
Juiz de Fora, Minas Gerais, Brazil
Gastrocentro Carioca Centro Gast e Endosc Dig, Ltda
Rio de Janeiro, Brazil
Hospital Israelita Albert Einstein
São Paulo, Brazil
Canada, British Columbia
Medical Arts Health Research Group
Penticton, British Columbia, Canada
Canada, Ontario
London Road Diagnostic Clinic and Medical Centre
Sarnia, Ontario, Canada
Dr Anil K Gupta Medicine Professional Corp.
Toronto, Ontario, Canada
Toronto Digestive Diseases Associates, Inc.
Toronto, Ontario, Canada
Canada, Quebec
Pro-Recherche Polyclinique des Ponts
Saint Romuald, Quebec, Canada
Czech Republic
Fakultní Nemocnice Ostrava
Ostrava, Severomoravsky Kraj, Czech Republic
Gastroenterologicka a interni ambulance
Ceské Budejovice, Czech Republic
Germany
Synexus Clinical Research GmbH
Magdeburg, Sachsen-anhalt, Germany
Synexus Clinical Research GmbH
Dresden, Sachsen, Germany
Synexus Clinical Research GmbH
Görlitz, Sachsen, Germany
Hungary
Pándy Kálmán Megyei Kórház
Gyula, Bekes, Hungary
Jahn Ferenc Dél-Pesti Kórház és Rendelointézet
Budapest, Hungary
Pannónia Magánorvosi Centrum Kft.
Budapest, Hungary
Semmelweis Egyetem
Budapest, Hungary
Vasútegészségügyi Nonprofit Kiemelten Közhasznú Kft
Debrecen, Hungary
Borsod Abaúj Zemplén Megyei Kórház és Egyetemi Oktató Kórház
Miskolc, Hungary
Miskolci Semmelweis Kórház és Egyetemi Oktatókórház
Miskolc, Hungary
Clinfan Szolgáltató Kft
Szekszárd, Hungary
CRU Hungary Kft.
Szikszó, Hungary
Jávorszky Ödön Kórház
Vác, Hungary
Mexico
Centro de Investigación Médico Biológica y Terapia Avanzada SC
Guadalajara, Jalisco, Mexico
Accelerium Clinical Research
Monterrey, Nuevo Leon, Mexico
Medical Care and Research
Mérida, Yucatan, Mexico
Hospital Centro Internacional de Medicina Chihuahua
Chihuahua, Mexico
Poland
Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy
Bydgoszcz, Kujawsko-pomorskie, Poland
Indywidualna Specjalistyczna Praktyka Lekarska Adam Kopon
Torun, Kujawsko-pomorskie, Poland
SPZOZ Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
Lódz, Lodzkie, Poland
Krakowskie Centrum Medyczne Sp. z o.o.
Kraków, Malopolskie, Poland
Medica Pro Familia Sp. z o.o. S.K.A.
Warszawa, Mazowieckie, Poland
Przychodnia Polskiej Fundacji Gastroenterologii Filia Nr 1 NZOZ
Warszawa, Mazowieckie, Poland
Medicor Centrum Medyczne Tadeusz Mazurek
Rzeszów, Podkarpackie, Poland
Slovakia
Lama Medical Care s.r.o., Gastroentero-hepatologicke centrum Thalion
Bratislava, Slovakia
PIGEAS s.r.o.
Martin, Slovakia
KM Management sro
Nitra, Slovakia
Gastro I.s.r.o.
Prešov, Slovakia
GEA s.r.o Gastroenterologicka ambulancia
Trnava, Slovakia
South Africa
JOSHA Research
Bloemfontein, Free State, South Africa
Synexus Clinical Research SA
Pretoria, Gauteng, South Africa
Dr. Zubar Fazel Vawda
Durban, KwaZulu-Natal, South Africa
Mzansi Ethical Research Centre
Middelburg, Mpumalanga, South Africa
Louis Leipoldt Medi-Clinic Medical Centre
Bellville, Western Cape, South Africa
Be Part Yoluntu Centre
Paarl, Western Cape, South Africa
Sweden
Sahlgrenska University Hospital
Gothenburg, Sweden
Karolinska University Hospital Huddinge
Stockholm, Sweden
Uppsala Akademiska Sjukhus
Uppsala, Sweden
United Kingdom
Synexus Lancashire Clinical Research Centre
Chorley, England, United Kingdom
Synexus Merseyside Clinical Research Centre
Liverpool, England, United Kingdom
Synexus Thames Valley Clinical Research Centre
Reading, England, United Kingdom
Synexus Scotland Clinical Research Centre
Glasgow, Scotland, United Kingdom
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01833065     History of Changes
Other Study ID Numbers: 000080
2012-005588-28 ( EudraCT Number )
First Posted: April 16, 2013    Key Record Dates
Results First Posted: October 20, 2015
Last Update Posted: October 20, 2015
Last Verified: September 2015

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