Dose-Finding Trial of Polyethylene Glycol 3350 Laxative Plus Electrolytes for the Treatment of Constipation (Protocol P07515)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01212445
First received: September 29, 2010
Last updated: February 17, 2016
Last verified: February 2016
  Purpose

The primary objective of the study was to evaluate the proportion of subjects with a bowel movement (BM) without straining or without hard and/or lumpy stool within the first 24 h of treatment for subjects taking 1 of 3 single doses of Polyethylene Glycol (PEG) plus Electrolytes (PEG+E) (13.125 g, 26.25 g, 39.375 g). The doses specified relate to the doses of PEG. Secondary objectives were measured by analysis of a subject diary and self-reported BM data. The secondary objectives included comparisons of PEG+E doses at 24 h for: BM control; relief of gas; relief of bloating; and relief of abdominal discomfort/cramping.

In addition, the proportion of subjects with a BM (without straining and without hard and/or lumpy stool) within the first 24 h of treatment for subjects taking different doses of PEG+E was evaluated for the time to first BM.


Condition Intervention Phase
Constipation
Drug: PEG 3350 laxative plus electrolytes (PEG + E)/Macrogol (Movicol®, BAY81-8430)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Dose-Finding Trial of Polyethylene Glycol 3350 Laxative Plus Electrolytes for the Treatment of Constipation

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Percentage of Participants With Successful Bowel Movement (BM) Within 24 Hours of PEG + E Administration [ Time Frame: From time of study drug treatment up to 24 hours ] [ Designated as safety issue: No ]
    A successful BM was defined as a BM with no straining or hard/lumpy stools.


Secondary Outcome Measures:
  • Number of Participants With Time To First Successful BM In 0 Days Through 0.5 Days, >0.5 Days Through 1.0 Days, or >1.0 Days Through 1.5 Days After PEG+E Administration [ Time Frame: From time of study drug administration up to 3 Days ] [ Designated as safety issue: No ]
    Time to first successful bowel movement was defined as the duration (in days) from the time of first study dose of study treatment until first successful BM (defined as BM without straining and without hard and/or lumpy stool).

  • Percentage of Participants With Successful BM Within 12 Hours of PEG+E Administration [ Time Frame: From time of study drug treatment up to 12 hours ] [ Designated as safety issue: No ]
    A successful BM was defined as a BM with no straining or hard/lumpy stools.

  • Mean Visual Analog Scale (VAS) Rating for BM Control [ Time Frame: From time of study drug treatment up to 24 hours ] [ Designated as safety issue: No ]

    The VAS is a psychometric response scale which measures responses along a continuum of values. The BM control VAS uses a 100 mm horizontal line with the two ends representing the opposite, extreme limits of the participant's experience of BM control. Participants marked where they felt they resided between the two ends with a vertical line. The distance from the left end of the VAS (0 mm) to the participant's mark was measured and recorded in mm. BM Control ratings ranged on a continuous scale from 0 to 100 mm, where 0 mm=Calm, not urgent and 100 mm= Not able to hold BM, very urgent.

    Participants completed a VAS after every BM or attempted BM. The VAS ratings recorded in the diaries for each BM were averaged (with range) to yield a single score for each participant. Participant scores were then averaged by treatment group


  • Mean VAS Rating for Gas [ Time Frame: From time of study drug treatment up to 24 hours ] [ Designated as safety issue: No ]

    The VAS is a psychometric response scale which measures responses along a continuum of values. The Gas VAS uses a 100 mm horizontal line with the two ends representing opposite, extreme limits of the participant's experience with BM-related gas. Participants marked where they felt they resided between the two ends with a vertical line. The distance from the left end of the VAS (0 mm) to the participant's mark was measured and recorded in mm. Gas ratings ranged on a continuous scale from 0 to 100 mm, where 0 mm=None and 100 mm= Severe.

    Participants completed a VAS after every BM or attempted BM. The VAS ratings recorded in the diaries for each BM were averaged (with range) to yield a single score for each participant. Participant scores were then averaged by treatment group.


  • Mean VAS Rating for Bloating [ Time Frame: From time of study drug treatment up to 24 hours ] [ Designated as safety issue: No ]

    The VAS is a psychometric response scale which measures responses along a continuum of values. The Bloating VAS uses a 100 mm horizontal line with the two ends representing opposite, extreme limits of the participant's experience with BM-related bloating. Participants marked where they felt they resided between the two ends with a vertical line. The distance from the left end of the VAS (0 mm) to the participant's mark was measured and recorded in mm. Bloating ratings ranged on a continuous scale from 0 to 100 mm, where 0 mm=None and 100 mm= Severe.

    Participants completed a VAS after every BM or attempted BM. The VAS ratings recorded in the diaries for each BM were averaged (with range) to yield a single score for each participant. Participant scores were then averaged by treatment group.


  • Mean VAS Rating for Abdominal Discomfort/Cramping [ Time Frame: From time of study drug treatment up to 24 hours ] [ Designated as safety issue: No ]

    The VAS is a psychometric response scale which measures responses along a continuum of values. The Abdominal Discomfort/Cramping VAS uses a 100 mm horizontal line with the two ends representing opposite, extreme limits of the participant's experience with BM-related abdominal discomfort/cramping. Participants marked where they felt they resided between the two ends with a vertical line. The distance from the left end of the VAS (0 mm) to the participant's mark was measured and recorded in mm. Abdominal discomfort/cramping ratings ranged on a continuous scale from 0 to 100 mm, where 0 mm=None and 100 mm= Painful.

    Participants completed a VAS after every BM or attempted BM. The VAS ratings recorded in the diaries for each BM were averaged (with range) to yield a single score for each participant. Participant scores were then averaged by treatment group.


  • Mean Participant Global Assessment of Treatment [ Time Frame: From time of study drug administration up to 2 Days ] [ Designated as safety issue: No ]
    At the End of Study Visit, the study staff asked the participant to rate their global assessment of the study treatment according to the following categories: 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, 4 = extremely effective.


Enrollment: 154
Study Start Date: October 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PEG + E, 13.125 g
Single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time
Drug: PEG 3350 laxative plus electrolytes (PEG + E)/Macrogol (Movicol®, BAY81-8430)
13.125 g of PEG 3350 powder with approximately 0.6 g of electrolytes
Experimental: PEG + E, 26.25 g
Two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time
Drug: PEG 3350 laxative plus electrolytes (PEG + E)/Macrogol (Movicol®, BAY81-8430)
13.125 g of PEG 3350 powder with approximately 0.6 g of electrolytes
Experimental: PEG + E, 39.375 g
Three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time
Drug: PEG 3350 laxative plus electrolytes (PEG + E)/Macrogol (Movicol®, BAY81-8430)
13.125 g of PEG 3350 powder with approximately 0.6 g of electrolytes

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A willingness to participate in the study and comply with its procedures
  • Must be ambulatory
  • Male or female subjects aged 18 years or older who met two or more of the following modified Rome III-based criteria for constipation: (a) straining during at least 25% of defecations; (b) lumpy or hard stools in at least 25% of defecations; (c) sensation of incomplete evacuation for at least 25% of defecation; (d) sensation of anorectal obstruction/blockage for at least 25% of defecations; (e) manual maneuvers to facilitate at least 25% of defecations (eg, digital evacuation, support of the pelvic floor), and (f) fewer than 3 defecations per week
  • Criteria fulfilled for the last 3 months with symptom onset at least 6 mo prior to diagnosis
  • Had a self reported or documented history of chronic constipation
  • Agreed not to use laxatives other than the study treatment from baseline/informed consent to end-of-study
  • Agreed to maintain a similar diet from the week before Visit 3 to the end-of-study were to be enrolled
  • Additionally required not to use any treatment known to cause constipation during the study (for subjects enrolled after Amendment 1)
  • If a female subject, either surgically sterile, 2 years postmenopausal, or using an acceptable method of contraception. Abstinence was not an acceptable method of contraception. Females of childbearing potential had to have a urine pregnancy test (human chorionic gonadotropin [HCG]) that was negative at Visit 3
  • Be able to read and write in the diaries in English

Exclusion Criteria:

  • Had loose stools without the use of laxatives
  • Recurrent abdominal pain
  • Known or suspected bowel perforation, obstruction, or fecal impaction; or had gastric retention, inflammatory bowel disease, bowel resection, or colostomy
  • Celiac disease or known gluten sensitivity
  • Known renal or hepatic insufficiency
  • Recent history of alcohol abuse or drug abuse
  • History of psychiatric disorders
  • History of significant ongoing medical problems or scheduled for surgical procedures
  • Subjects who, in the opinion of the Investigator, should not have been included in the study for any reason, including inability to follow study procedures
  • Participated in an investigational clinical, surgical, drug or device study within the past 30 days
  • Pregnant or lactating
  • Allergic to PEG or PEG+E
  • Employed by or have immediate family members employed by a company that manufactures laxative products
  • Participant or family member of the Investigator or site staff directly involved with this study
  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: NCT01212445

Locations
Ireland
ORK, Ireland
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01212445     History of Changes
Other Study ID Numbers: 18129  2010-021367-32 
Study First Received: September 29, 2010
Results First Received: November 20, 2012
Last Updated: February 17, 2016
Health Authority: Ireland: Irish Medicines Board

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Laxatives
Polyethylene glycol 3350
Cathartics
Gastrointestinal Agents

ClinicalTrials.gov processed this record on August 30, 2016