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):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01212445
First received: September 29, 2010
Last updated: February 28, 2014
Last verified: February 2014

September 29, 2010
February 28, 2014
September 2010
November 2011   (final data collection date for primary outcome measure)
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.
Proportion of participants with successful bowel movement ([BM] i.e. BM with no straining or hard/lumpy stools) within 24 hours of dosing. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01212445 on ClinicalTrials.gov Archive Site
  • 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.
  • Visual Analog Scale (VAS) ratings for bowel movement control [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Recorded daily on a home-use diary the time of each bowel movement through the course of the 24-hour treatment period.
  • VAS ratings for relief of gas [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Recorded daily on a home-use diary the time of each bowel movement through the course of the 24-hour treatment period.
  • VAS ratings for relief of bloating [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • VAS ratings for relief of abdominal discomfort/cramping [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Recorded daily on a home-use diary the time of each bowel movement through the course of the 24-hour treatment period.
  • Time to first bowel movement [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Proportion of participants with successful BM within 12 hours [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
  • Participant's Global Assessment [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Participant to rate their global assessment of the study treatment according to the categories:0 = not at all effective; 1 = a little bit effective; 2 = moderately effective; 3 = quite a bit effective; and 4 = extremely effective
Not Provided
Not Provided
 
Dose-Finding Trial of Polyethylene Glycol 3350 Laxative Plus Electrolytes for the Treatment of Constipation (Protocol P07515)
A Randomized, Open-Label, Dose-Finding Trial of Polyethylene Glycol 3350 Laxative Plus Electrolytes for the Treatment of Constipation

This study will investigate the optimal dose of Polyethylene Glycol plus Electrolytes (PEG+E) that will provide fast-acting relief of constipation without cramping, bloating or other unpleasant gastrointestinal (GI) side effects.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Constipation
  • Drug: Polyethylene Glycol plus Electrolytes (PEG+E)
    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
    Other Name: Movicol® (SCH 900114)
  • Drug: Polyethylene Glycol plus Electrolytes (PEG+E)
    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
    Other Name: Movicol® (SCH 900114)
  • Drug: Polyethylene Glycol plus Electrolytes (PEG+E)
    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
    Other Name: Movicol® (SCH 900114)
  • Experimental: PEG + E 13.125 g
    Intervention: Drug: Polyethylene Glycol plus Electrolytes (PEG+E)
  • Experimental: PEG + E 26.25 g
    Intervention: Drug: Polyethylene Glycol plus Electrolytes (PEG+E)
  • Experimental: PEG + E 39.375 g
    Intervention: Drug: Polyethylene Glycol plus Electrolytes (PEG+E)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
154
November 2011
November 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • A willingness to participate in the study and comply with its procedures.
  • Must be ambulatory.
  • Have stools less often than three times weekly and meet one or more of the following modified

Rome III-based criteria for constipation:

  • Straining during all defecations
  • Lumpy or hard stools in at least 25% of defecations
  • Sensation of incomplete evacuation for at least 25% of defecations
  • Sensation of anorectal obstruction/blockage for at least 25% of defecations
  • Manual maneuvers to facilitate at least 25% of defecations (e.g., digital evacuation,

support of the pelvic floor)

  • Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis.
  • Agrees not to use any treatment known to cause constipation during the course of the study, beginning at prestudy (Visit 1).
  • Agrees not to use laxatives other than the study treatment from baseline/informed consent (Visit 2) to end-of-study (Visit 4).
  • Agrees to maintain a similar diet from the week prior to Visit 3 through end-of-study.
  • If a female participant, either surgically sterile, 2 years postmenopausal, or using an acceptable method of contraception (including hormonal birth control, intra-uterine device (IUD), double barrier methods, or vasectomized partner). Abstinence is not an acceptable method of contraception. Females of childbearing potential must have a urine pregnancy test (human chorionic gonadotropin [HCG]) that is negative at Visit 3.
  • Be able to read and write in the diaries in English.

Exclusion Criteria:

  • Have loose stools without the use of laxatives.
  • Recurrent abdominal pain (if it is the predominant symptom of constipation).
  • 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 cardiac, renal, or hepatic insufficiency.
  • Recent history of alcohol abuse (in the Investigator's opinion) or drug abuse.
  • History of psychiatric disorders. Currently clinically stable participants (in the Investigator's opinion) may be included.
  • History of significant (in the Investigator's opinion) ongoing medical problems (including acute infections, renal or gastrointestinal disease) or who are scheduled for surgical procedures. All clinically significant medical or surgical conditions, which in the opinion of the investigator, merit exclusion.
  • Participants who, in the opinion of the Investigator, should not be 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01212445
P07515, 2010-021367-32
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
February 2014

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