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出境医 / 临床实验 / Efficacy and Safety of PEG 3350 for Treatment of Chronic Constipation

Efficacy and Safety of PEG 3350 for Treatment of Chronic Constipation

Study Description
Brief Summary:
The aim of this study is to determine the efficacy and safety of PEG 3350 (polyethylene glycol 3350) for short-term treatment of chronic constipation in adults.

Condition or disease Intervention/treatment Phase
Constipation - Functional Drug: PEG 3350 Drug: Lactulose Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of PEG 3350 for Treatment of Chronic Constipation
Actual Study Start Date : December 7, 2019
Actual Primary Completion Date : September 30, 2020
Estimated Study Completion Date : October 31, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: PEG 3350
The content of each sachet of PEG 3350 (17 g powder) is dissolved in 240 mL of water, drink it once daily at bedtime, for a duration of 14 days.
 Drug: PEG 3350
PEG 3350 17 g once daily for 14 days
Active Comparator: Lactulax
15 ml of Lactulax syrup (containing 10 g of lactulose) is drunk with 240 ml of water once daily at bedtime, for a duration of 14 days
 Drug: Lactulose
Lactulose 10 g once daily for 14 days
Outcome Measures
Primary Outcome Measures :
  1. Change of number of bowel movements at 1 week [ Time Frame: 7 days ]
    An increase in the number of bowel movements (defecation) per 7-day period indicates a positive result.

  2. Change of number of bowel movements at 2 weeks [ Time Frame: 14 days ]
    An increase in the number of bowel movements (defecation) per 7-day period indicates a positive result.


Secondary Outcome Measures :
  1. Symptom scores at 1 week [ Time Frame: 7 days ]
    • Stool consistency: 0 = hard, 1 = firm, 2 = soft, 3 = loose, 4 = watery (by anamnesis - visual comparison)
    • Stool passage: 0 = strain, 1 = easy, 2 = loss of control (by anamnesis)
    • Cramping and rectal irritation associated with each bowel movement: 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = have to discontinue (by anamnesis)
    • Flatus: 0 = none, 1 = moderate, 2 = occasional, 3 = frequent, 4 = very frequent

  2. Symptom scores at 2 weeks [ Time Frame: 14 days ]
    • Stool consistency: 0 = hard, 1 = firm, 2 = soft, 3 = loose, 4 = watery (by anamnesis - visual comparison)
    • Stool passage: 0 = strain, 1 = easy, 2 = loss of control (by anamnesis)
    • Cramping and rectal irritation associated with each bowel movement: 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = have to discontinue (by anamnesis)
    • Flatus: 0 = none, 1 = moderate, 2 = occasional, 3 = frequent, 4 = very frequent

  3. Overall rating of effectiveness at 1 week [ Time Frame: 7 days ]
    Effective: patients with ≥ 3 bowel movements per 7-day period

  4. Overall rating of effectiveness at 2 weeks [ Time Frame: 14 days ]
    Effective: patients with ≥ 3 bowel movements per 7-day period


Other Outcome Measures:
  1. Number of participants with adverse events (AEs) [ Time Frame: 7 days, 14 days ]

    The following adverse events may occur after treatment, thus will be evaluated:

    • Headache
    • Dizziness
    • Fatigue
    • Weakness
    • Nausea
    • Dry mouth
    • Abdominal pain / cramping
    • Flatulence
    • Rectal irritation
    • Diarrhea / watery stool

  2. Number of participants with serious adverse events (SAEs) [ Time Frame: 7 days, 14 days ]

Eligibility Criteria
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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:

  1. Males and females aged ≥ 18 years.
  2. Body Mass Index (BMI) ≥ 18.5
  3. Organic bowel disease will be ruled out by Fecal Immunochemical Test (FIT) and/or colonoscopy.
  4. Must have ≤ 2 bowel movements during a 7-day qualification period.
  5. In otherwise good health as judged by a physical examination and laboratory testing.
  6. Not taking medications known to affect bowel function in one week before study.
  7. Willing to participate in the study by signing the informed consent.

Exclusion Criteria:

  1. Hypersensitive to the study medication.
  2. obstructive ileus.
  3. Irritable bowel syndrome (IBS) or inflammatory bowel disease (IBD)
Contacts and Locations

Locations
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Indonesia
Puskesmas Kelurahan Petamburan
Jakarta, DKI Jakarta, Indonesia, 10260
RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital)
Jakarta, DKI Jakarta, Indonesia, 10430
Puskesmas Kelurahan Paseban
Jakarta, DKI Jakarta, Indonesia, 10440
Sponsors and Collaborators
Fakultas Kedokteran Universitas Indonesia
PT Meiji Indonesia
Investigators
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Principal Investigator: Murdani Abdulah Fakultas Kedokteran Universitas Indonesia
Tracking Information
First Submitted Date  ICMJE May 10, 2019
First Posted Date  ICMJE May 21, 2019
Last Update Posted Date October 20, 2020
Actual Study Start Date  ICMJE December 7, 2019
Actual Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 19, 2019)
  • Change of number of bowel movements at 1 week [ Time Frame: 7 days ]
    An increase in the number of bowel movements (defecation) per 7-day period indicates a positive result.
  • Change of number of bowel movements at 2 weeks [ Time Frame: 14 days ]
    An increase in the number of bowel movements (defecation) per 7-day period indicates a positive result.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2019)
  • Symptom scores at 1 week [ Time Frame: 7 days ]
    • Stool consistency: 0 = hard, 1 = firm, 2 = soft, 3 = loose, 4 = watery (by anamnesis - visual comparison)
    • Stool passage: 0 = strain, 1 = easy, 2 = loss of control (by anamnesis)
    • Cramping and rectal irritation associated with each bowel movement: 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = have to discontinue (by anamnesis)
    • Flatus: 0 = none, 1 = moderate, 2 = occasional, 3 = frequent, 4 = very frequent
  • Symptom scores at 2 weeks [ Time Frame: 14 days ]
    • Stool consistency: 0 = hard, 1 = firm, 2 = soft, 3 = loose, 4 = watery (by anamnesis - visual comparison)
    • Stool passage: 0 = strain, 1 = easy, 2 = loss of control (by anamnesis)
    • Cramping and rectal irritation associated with each bowel movement: 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = have to discontinue (by anamnesis)
    • Flatus: 0 = none, 1 = moderate, 2 = occasional, 3 = frequent, 4 = very frequent
  • Overall rating of effectiveness at 1 week [ Time Frame: 7 days ]
    Effective: patients with ≥ 3 bowel movements per 7-day period
  • Overall rating of effectiveness at 2 weeks [ Time Frame: 14 days ]
    Effective: patients with ≥ 3 bowel movements per 7-day period
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 19, 2019)
  • Number of participants with adverse events (AEs) [ Time Frame: 7 days, 14 days ]
    The following adverse events may occur after treatment, thus will be evaluated:
    • Headache
    • Dizziness
    • Fatigue
    • Weakness
    • Nausea
    • Dry mouth
    • Abdominal pain / cramping
    • Flatulence
    • Rectal irritation
    • Diarrhea / watery stool
  • Number of participants with serious adverse events (SAEs) [ Time Frame: 7 days, 14 days ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of PEG 3350 for Treatment of Chronic Constipation
Official Title  ICMJE Efficacy and Safety of PEG 3350 for Treatment of Chronic Constipation
Brief Summary The aim of this study is to determine the efficacy and safety of PEG 3350 (polyethylene glycol 3350) for short-term treatment of chronic constipation in adults.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Constipation - Functional
Intervention  ICMJE
  • Drug: PEG 3350
    PEG 3350 17 g once daily for 14 days
  • Drug: Lactulose
    Lactulose 10 g once daily for 14 days
Study Arms  ICMJE
  • Experimental: PEG 3350
    The content of each sachet of PEG 3350 (17 g powder) is dissolved in 240 mL of water, drink it once daily at bedtime, for a duration of 14 days.
    Intervention: Drug: PEG 3350
  • Active Comparator: Lactulax
    15 ml of Lactulax syrup (containing 10 g of lactulose) is drunk with 240 ml of water once daily at bedtime, for a duration of 14 days
    Intervention: Drug: Lactulose
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: May 19, 2019) 		184
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2020
Actual Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Males and females aged ≥ 18 years.
  2. Body Mass Index (BMI) ≥ 18.5
  3. Organic bowel disease will be ruled out by Fecal Immunochemical Test (FIT) and/or colonoscopy.
  4. Must have ≤ 2 bowel movements during a 7-day qualification period.
  5. In otherwise good health as judged by a physical examination and laboratory testing.
  6. Not taking medications known to affect bowel function in one week before study.
  7. Willing to participate in the study by signing the informed consent.

Exclusion Criteria:

  1. Hypersensitive to the study medication.
  2. obstructive ileus.
  3. Irritable bowel syndrome (IBS) or inflammatory bowel disease (IBD)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Indonesia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03957668
Other Study ID Numbers  ICMJE 19-04-0392
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Murdani Abdullah, Fakultas Kedokteran Universitas Indonesia
Study Sponsor  ICMJE Fakultas Kedokteran Universitas Indonesia
Collaborators  ICMJE PT Meiji Indonesia
Investigators  ICMJE
Principal Investigator: Murdani Abdulah Fakultas Kedokteran Universitas Indonesia
PRS Account Fakultas Kedokteran Universitas Indonesia
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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