Movicol in Childhood Constipation (ProMotion Study)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-10-31

Study Completion Date

2002-07-31

Brief Summary

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This was a single centre study comprised of two stages (Parts I and II). Part II was a 12 week randomised double blind comparison of Movicol and Lactulose Dry as maintenance therapy on an out-patient basis. The aim was to evaluate the safety and efficacy of Movicol in the treatment of faecal impaction in children

Detailed Description

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Two days following disimpaction (Part I of the clinical trial) patients were assigned (based on their randomisation number) to receive either Movicol or Lactulose as maintenance therapy for the remainder of the study. At discharge all patients received the appropriate supply of study medication. This includes 1 week's overage should they miss their next visit to the ProMotion clinic. They did not know whether they have been randomised to receive Movicol or Lactulose Dry.

Following discharge patients were contacted after 3-5 days by telephone or home visit (whichever was appropriate) to encourage treatment and to ensure compliance. Parents were instructed to contact the Pro-Motion team who would advise appropriately if patients had any difficulty i.e. none, irregular and/ or uncomfortable or very loose bowel movements.

The daily use of Movicol or Lactulose Dry during Part II was recorded in the diary. If the dose of Movicol or Lactulose was changed by the Pro-Motion team at any time then it was documented appropriately in the patient notes and the case report form.

Conditions

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Chronic Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Polyethylene glycol 3350 NA bicarbonate NaCl KCl (Movicol)

Intervention Type DRUG

Lactulose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients that, in the opinion of the investigator, are constipated/faecally impacted as to require hospital stay to treat and/or relieve the impaction
* children aged 2 - 11 years old inclusive
* patients of either sex

Exclusion Criteria

Patients with

* intestinal perforation or obstruction
* severe inflammatory conditions of the intestinal tract
* uncontrolled renal/hepatic/cardiac diseases
* uncontrolled endocrine disorder(s)
* any neuromuscular condition affecting bowel function
* hypersensitivity to lactulose or PEG or other constituent of Movicol
* patients who have taken any investigational drug in the three months
* patients or patients whose parents would in the opinion of the investigator are unable to comply with requirements of the study

Minimum Eligible Age

2 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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David CA Candy, MD

Role: PRINCIPAL_INVESTIGATOR

St. Richard's Hospital

Locations

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St Richard's Hospital, Royal West Sussex Hospital NHS Trust

Chichester, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Dalziel SR et al. Efficacy of Movicol in children with faecal impaction. A series of en case histories (A13). British Society of Paediatric Gastroenterologists Annual Meeting. Bristol:21-22, Jan 2000

Reference Type BACKGROUND

Attar A, Lemann M, Ferguson A, Halphen M, Boutron MC, Flourie B, Alix E, Salmeron M, Guillemot F, Chaussade S, Menard AM, Moreau J, Naudin G, Barthet M. Comparison of a low dose polyethylene glycol electrolyte solution with lactulose for treatment of chronic constipation. Gut. 1999 Feb;44(2):226-30. doi: 10.1136/gut.44.2.226.

Reference Type BACKGROUND

PMID: 9895382 (View on PubMed)

Candy DC, Edwards D, Geraint M. Treatment of faecal impaction with polyethelene glycol plus electrolytes (PGE + E) followed by a double-blind comparison of PEG + E versus lactulose as maintenance therapy. J Pediatr Gastroenterol Nutr. 2006 Jul;43(1):65-70. doi: 10.1097/01.mpg.0000228097.58960.e6.

Reference Type RESULT

PMID: 16819379 (View on PubMed)

Other Identifiers

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99/05 (Part II)

Identifier Type: -

Identifier Source: org_study_id