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Bowel Preparation for ColonoscopyPhase 3NCT01929590

Low-volume Polyethylene Glycol Bowel Preparation for Colonoscopy

A Phase 3 study testing PEG-3350 group 2, PEG-3350 group 1 and PEG-3350 group 3 in people with Bowel Preparation for Colonoscopy, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

the efficacy and tolerability of a low-volume (2 L) PEG regimen for colonoscopy compared to single (4 L) or split-dose (2 L + 2 L) treatments are not different. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Bowel Preparation for Colonoscopy
What is being tested?
PEG-3350 group 2, PEG-3350 group 1 and PEG-3350 group 3
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteMexico
Study dates
Oct 2011to Jun 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • In-hospital patients with an indication for colonoscopy

Who cannot join

  • patients under 18 years of age
  • the presence of a severe illness (cardiac, renal, or metabolic)
  • major psychiatric illness
  • known allergies to PEG-3350
  • refusal to consent to the study

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Instituto Nacional de ciencias Médicas y Nutrición Salvador Zubirán

    Mexico City, Mexico City, 14000

Other trials in Mexico

About this study

Official title: Efficacy and Tolerability of Low-volume Polyethylene Glycol (2 L) vs. Single- (4 L) vs. Split-dose (2L + 2L) of Polyethylene Glycol Bowel Preparation for Colonoscopy: a Randomized Clinical Trial.

the efficacy and tolerability of a low-volume (2 L) PEG regimen for colonoscopy compared to single (4 L) or split-dose (2 L + 2 L) treatments are not different.

Read the detailed description

In-hospital patients were randomly assigned to one of three groups: group 1 single dose (PEG-3350; PEG-4 L the day previous of the study, starting at 17:00 and finishing at 21:00 h); group 2: split-dose (PEG-3350; 2 L the day before 17:00-19:00 h and 2 L same day of the procedure 06:00-08:00 am); group 3: low-volume 2 L PEG-solution (same day of the procedure 06:00-08:00 am).

The quality of colonic preparation was assessed by the Boston bowel preparation scale (13); tolerability (nausea, vomiting, and abdominal pain), compliance, sleep disturbance and adverse effects in group 3 were compared with those in groups 1 and 2. The time since the last dose of bowel-preparation agent, the time since the last solid food was consumed, the approximate amount of bowel preparation taken (0%, 25%, 75%, or 100%), and the start time of the colonoscopy were recorded.

Satisfactory colon preparation was considered when scores of the Boston bowel preparation scale were 2/3; otherwise, the procedure was considered unsatisfactory preparation.

Being tested
PEG-3350 group 2, PEG-3350 group 1, PEG-3350 group 3
Keywords
Colonoscopy, Preparation, Polyp, Polyethylene glycol
Medical subject headings
Polyps

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PEG-3350 group 2Drug

    Also called Nulytely

    split-dose (PEG-3350; 2 L the day before 17:00-19:00 h and 2 L same day of the procedure 06:00-08:00 am)

  • PEG-3350 group 1Drug

    Also called Nulytely

    PEG-3350; PEG-4 L the day previous of the study, starting at 17:00 and finishing at 21:00 h

  • PEG-3350 group 3Drug

    Also called Nulytely

    low-volume 2 L PEG-solution (same day of the procedure 06:00-08:00 am)

Study groups in NCT01929590
Study groupRoleWhat they receive
PEG-3350 group 3Active comparatorgroup 3: low-volume 2 L PEG-3350 solution (same day of the procedure 06:00-08:00 am).
Receives: Drug: PEG-3350 group 3
PEG-3350 group 1Active comparatorgroup 1 single dose (PEG-3350; PEG-4 L the day previous of the study, starting at 17:00 and finishing at 21:00 h)
Receives: Drug: PEG-3350 group 1
PEG-3350 group 2Experimentalgroup 2: split-dose (PEG-3350 2 L the day before 17:00-19:00 h and 2 L same day of the procedure 06:00-08:00 am)
Receives: Drug: PEG-3350 group 2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. satisfactory bowel preparation

    The aim of this study was to test the quality of bowel preparation and tolerability of a low-volume (2 L) PEG regimen for colonoscopy compared to single (4 L) or split-dose (2 L + 2 L) treatments. The quality of colonic preparation was assessed by the Boston bowel preparation scale.Satisfactory colon preparation was considered when scores of the Boston bowel preparation scale were 2/3; otherwise, the procedure was considered unsatisfactory preparation.

    Measured: at the moment of colonoscopy

Secondary outcomes (1)

  1. tolerability with bowel preparation

    tolerability of bowel preparation was measured, considering: nausea, vomiting, and abdominal pain, compliance, sleep disturbance and adverse effects.

    Measured: just before to start the colonoscopy and before any sedative be administered

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2013 (estimated)
  2. Study startOct 2011
  3. Primary completionJun 2012
  4. Study completionJun 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01929590
Sponsor's protocol ID
end-407-11-11-1
Status last verified
Aug 2013
First submitted
2 Aug 2013
Last updated
28 Aug 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Hassan C, Bretthauer M, Kaminski MF, Polkowski M, Rembacken B, Saunders B, Benamouzig R, Holme O, Green S, Kuiper T, Marmo R, Omar M, Petruzziello L, Spada C, Zullo A, Dumonceau JM; European Society of Gastrointestinal Endoscopy. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy. 2013;45(2):142-50. doi: 10.1055/s-0032-1326186. Epub 2013 Jan 18.

    PubMed 23335011

  • Corporaal S, Kleibeuker JH, Koornstra JJ. Low-volume PEG plus ascorbic acid versus high-volume PEG as bowel preparation for colonoscopy. Scand J Gastroenterol. 2010 Nov;45(11):1380-6. doi: 10.3109/00365521003734158. Epub 2010 Jul 5.

    PubMed 20602568

  • Adams WJ, Meagher AP, Lubowski DZ, King DW. Bisacodyl reduces the volume of polyethylene glycol solution required for bowel preparation. Dis Colon Rectum. 1994 Mar;37(3):229-33; discussion 233-4. doi: 10.1007/BF02048160.

    PubMed 8137669

  • Jansen SV, Goedhard JG, Winkens B, van Deursen CT. Preparation before colonoscopy: a randomized controlled trial comparing different regimes. Eur J Gastroenterol Hepatol. 2011 Oct;23(10):897-902. doi: 10.1097/MEG.0b013e32834a3444.

    PubMed 21900786

  • Marmo R, Rotondano G, Riccio G, Marone A, Bianco MA, Stroppa I, Caruso A, Pandolfo N, Sansone S, Gregorio E, D'Alvano G, Procaccio N, Capo P, Marmo C, Cipolletta L. Effective bowel cleansing before colonoscopy: a randomized study of split-dosage versus non-split dosage regimens of high-volume versus low-volume polyethylene glycol solutions. Gastrointest Endosc. 2010 Aug;72(2):313-20. doi: 10.1016/j.gie.2010.02.048. Epub 2010 Jun 19.

    PubMed 20561621

  • Pontone S, Angelini R, Standoli M, Patrizi G, Culasso F, Pontone P, Redler A. Low-volume plus ascorbic acid vs high-volume plus simethicone bowel preparation before colonoscopy. World J Gastroenterol. 2011 Nov 14;17(42):4689-95. doi: 10.3748/wjg.v17.i42.4689.

    PubMed 22180711

  • Ell C, Fischbach W, Bronisch HJ, Dertinger S, Layer P, Runzi M, Schneider T, Kachel G, Gruger J, Kollinger M, Nagell W, Goerg KJ, Wanitschke R, Gruss HJ. Randomized trial of low-volume PEG solution versus standard PEG + electrolytes for bowel cleansing before colonoscopy. Am J Gastroenterol. 2008 Apr;103(4):883-93. doi: 10.1111/j.1572-0241.2007.01708.x. Epub 2008 Jan 11.

    PubMed 18190651

  • Abut E, Guveli H, Yasar B, Bolukbas C, Bolukbas FF, Ince AT, Kendir T, Dalay AR, Kurdas OO. Administration of olive oil followed by a low volume of polyethylene glycol-electrolyte lavage solution improves patient satisfaction with right-side colonic cleansing over administration of the conventional volume of polyethylene glycol-electrolyte lavage solution for colonoscopy preparation. Gastrointest Endosc. 2009 Sep;70(3):515-21. doi: 10.1016/j.gie.2009.01.002. Epub 2009 Jun 24.

    PubMed 19555936

  • Enestvedt BK, Brian Fennerty M, Zaman A, Eisen GM. MiraLAX vs. Golytely: is there a significant difference in the adenoma detection rate? Aliment Pharmacol Ther. 2011 Oct;34(7):775-82. doi: 10.1111/j.1365-2036.2011.04795.x. Epub 2011 Aug 17.

    PubMed 21848798

  • Haapamaki MM, Lindstrom M, Sandzen B. Low-volume bowel preparation is inferior to standard 4 1 polyethylene glycol. Surg Endosc. 2011 Mar;25(3):897-901. doi: 10.1007/s00464-010-1293-6. Epub 2010 Sep 2.

    PubMed 20812020

  • DiPalma JA, McGowan J, Cleveland MV. Clinical trial: an efficacy evaluation of reduced bisacodyl given as part of a polyethylene glycol electrolyte solution preparation prior to colonoscopy. Aliment Pharmacol Ther. 2007 Oct 15;26(8):1113-9. doi: 10.1111/j.1365-2036.2007.03459.x.

    PubMed 17894653

  • Hookey LC, Depew WT, Vanner SJ. Combined low volume polyethylene glycol solution plus stimulant laxatives versus standard volume polyethylene glycol solution: a prospective, randomized study of colon cleansing before colonoscopy. Can J Gastroenterol. 2006 Feb;20(2):101-5. doi: 10.1155/2006/621367.

    PubMed 16482236

  • Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):620-5. doi: 10.1016/j.gie.2008.05.057. Epub 2009 Jan 10.

    PubMed 19136102

  • Siddiqui AA, Yang K, Spechler SJ, Cryer B, Davila R, Cipher D, Harford WV. Duration of the interval between the completion of bowel preparation and the start of colonoscopy predicts bowel-preparation quality. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):700-6. doi: 10.1016/j.gie.2008.09.047.

    PubMed 19251013

  • Seo EH, Kim TO, Park MJ, Joo HR, Heo NY, Park J, Park SH, Yang SY, Moon YS. Optimal preparation-to-colonoscopy interval in split-dose PEG bowel preparation determines satisfactory bowel preparation quality: an observational prospective study. Gastrointest Endosc. 2012 Mar;75(3):583-90. doi: 10.1016/j.gie.2011.09.029. Epub 2011 Dec 15.

    PubMed 22177570

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PEG-3350 group 2, PEG-3350 group 1 and PEG-3350 group 3 in people with Bowel Preparation for Colonoscopy, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

satisfactory bowel preparation (time frame: at the moment of colonoscopy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01929590, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2013.

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