Back to resultsDose-Finding Trial of Polyethylene Glycol 3350 Laxative Plus Electrolytes for the Treatment of Constipation (Protocol P07515)
Primary Purpose
Constipation
Status
Completed
Phase
Phase 2
Locations
Ireland
Study Type
Interventional
Intervention
PEG 3350 laxative plus electrolytes (PEG + E)/Macrogol (Movicol®, BAY81-8430)
Sponsored by
About this trial
This is an interventional treatment trial for Constipation
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
PEG + E, 13.125 g
PEG + E, 26.25 g
PEG + E, 39.375 g
Arm Description
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
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
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
Outcomes
Primary Outcome Measures
Percentage of Participants With Successful Bowel Movement (BM) Within 24 Hours of PEG + E Administration
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 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
A successful BM was defined as a BM with no straining or hard/lumpy stools.
Mean Visual Analog Scale (VAS) Rating for BM Control
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
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
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01212445
Brief Title
Dose-Finding Trial of Polyethylene Glycol 3350 Laxative Plus Electrolytes for the Treatment of Constipation (Protocol P07515)
Official Title
A Randomized, Open-Label, Dose-Finding Trial of Polyethylene Glycol 3350 Laxative Plus Electrolytes for the Treatment of Constipation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
154 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PEG + E, 13.125 g
Arm Type
Experimental
Arm Description
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
Arm Title
PEG + E, 26.25 g
Arm Type
Experimental
Arm Description
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
Arm Title
PEG + E, 39.375 g
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
PEG 3350 laxative plus electrolytes (PEG + E)/Macrogol (Movicol®, BAY81-8430)
Intervention Description
13.125 g of PEG 3350 powder with approximately 0.6 g of electrolytes
Primary Outcome Measure Information:
Title
Percentage of Participants With Successful Bowel Movement (BM) Within 24 Hours of PEG + E Administration
Description
A successful BM was defined as a BM with no straining or hard/lumpy stools.
Time Frame
From time of study drug treatment up to 24 hours
Secondary Outcome Measure Information:
Title
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
Description
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).
Time Frame
From time of study drug administration up to 3 Days
Title
Percentage of Participants With Successful BM Within 12 Hours of PEG+E Administration
Description
A successful BM was defined as a BM with no straining or hard/lumpy stools.
Time Frame
From time of study drug treatment up to 12 hours
Title
Mean Visual Analog Scale (VAS) Rating for BM Control
Description
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
Time Frame
From time of study drug treatment up to 24 hours
Title
Mean VAS Rating for Gas
Description
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.
Time Frame
From time of study drug treatment up to 24 hours
Title
Mean VAS Rating for Bloating
Description
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.
Time Frame
From time of study drug treatment up to 24 hours
Title
Mean VAS Rating for Abdominal Discomfort/Cramping
Description
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.
Time Frame
From time of study drug treatment up to 24 hours
Title
Mean Participant Global Assessment of Treatment
Description
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.
Time Frame
From time of study drug administration up to 2 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
ORK
Country
Ireland
12. IPD Sharing Statement
Links:
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe.
Learn more about this trial
Dose-Finding Trial of Polyethylene Glycol 3350 Laxative Plus Electrolytes for the Treatment of Constipation (Protocol P07515)
We'll reach out to this number within 24 hrs