Phase 2
N=154
Dose-Finding Trial of Polyethylene Glycol 3350 Laxative Plus Electrolytes for the Treatment of Constipation (Protocol P07515)
Constipation
Bottom Line
View on ClinicalTrials.gov: NCT01212445 ↗Enrolled (actual)
154
Serious AEs
0.0%
Results posted
Mar 2013
Primary outcome: Primary: Percentage of Participants With Successful Bowel Movement (BM) Within 24 Hours of PEG + E Administration — 19.2; 31.4; 19.2 percentage of participants — p=0.1790
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- PEG 3350 laxative plus electrolytes (PEG + E)/Macrogol (Movicol®, BAY81-8430) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Successful Bowel Movement (BM) Within 24 Hours of PEG + E Administration |
19.2; 31.4; 19.2 | 0.1790 |
| SECONDARY 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 |
4; 8; 6; 6; 8; 4 | — |
| SECONDARY Percentage of Participants With Successful BM Within 12 Hours of PEG+E Administration |
7.7; 15.7; 11.8 | 0.2350 |
| SECONDARY Mean Visual Analog Scale (VAS) Rating for BM Control |
31.1; 23.5; 29.4 | 0.1876 |
| SECONDARY Mean VAS Rating for Gas |
23.9; 25.4; 26.0 | 0.8109 |
| SECONDARY Mean VAS Rating for Bloating |
33.9; 21.7; 32.7 | 0.0486 sig |
| SECONDARY Mean VAS Rating for Abdominal Discomfort/Cramping |
17.4; 14.0; 14.5 | 0.4591 |
| SECONDARY Mean Participant Global Assessment of Treatment |
1.0; 1.3; 1.2 | 0.1865 |
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.
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
Data sourced from ClinicalTrials.gov (NCT01212445). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.