Randomized Controlled Trial of Treating Rectal Hypersensitivity - Comparing Escitalopram With Sensory Adaptation Training

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by University of Iowa.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Iowa
ClinicalTrials.gov Identifier:
NCT00584571
First received: December 21, 2007
Last updated: February 18, 2011
Last verified: February 2011

December 21, 2007
February 18, 2011
December 2007
February 2012   (final data collection date for primary outcome measure)
Rectal Sensory Thresholds [ Time Frame: Trial entry and at the end of 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00584571 on ClinicalTrials.gov Archive Site
Global Symptom Assessment (GSA) of abdominal discomfort/pain [ Time Frame: Trial entry and at the end of 3 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Randomized Controlled Trial of Treating Rectal Hypersensitivity - Comparing Escitalopram With Sensory Adaptation Training
Not Provided

Constipation is a common digestive disorder. After excluding dietary factors, drugs and other secondary causes, at least three broad pathophysiologic subtypes are recognized- dyssynergic defecation, constipation-predominant irritable bowel syndrome (IBS-C) and slow transit constipation (STC), all predominantly affect women and elderly. Many patients also demonstrate abnormal rectal perception with both rectal hyposensitivity and hypersensitivity being common. Recent surveys show that most constipated patients are dissatisfied with current therapy. Also, constipated patients showed significant psychological dysfunction and impaired quality of life. OBJECTIVE: To investigate a novel biofeedback technique of improving rectal hypersensitivity.

METHODS: A large compliant balloon attached to a barostat was placed in the rectum in 8 patients with rectal hypersensitivity (urgency/pain threshold <30 mm Hg). Sensory deconditioning was performed by incremental balloon distensions (1-2 mmHg) until normal thresholds were reached.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Rectal Hypersensitivity
  • Irritable Bowel Syndrome-Constipation
  • Procedure: Sensory Adaptation Training with Barostat
    This study will last for approximately 3 months and will include 4-6 clinic visits with each visit lasting 2 hours every week or every 2 weeks. At the beginning of each visit we will ask you about your health status and level of satisfaction of your bowel habits. We will then place the pencil-thick probe and balloon inside your rectum and attach it to the barostat device and a computer. We will increase and decrease the volumes of the balloon until the most pressure you can tolerate or a certain level of pressure as measured by the machine is reached, whichever occurs first. You will continue to keep stool diaries and pain diaries for 7 days before and after each visit.
    Other Name: Barostat procedure
  • Drug: Escitalopram Therapy
    Escitalopram; 10 mg every day, orally.
    Other Name: Lexapro (Escitalopram) therapy
  • Active Comparator: Sensory Adaptation
    Intervention: Procedure: Sensory Adaptation Training with Barostat
  • Experimental: Escitalopram Therapy
    Intervention: Drug: Escitalopram Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
June 2012
February 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

All patients must fulfill the diagnostic criteria for IBS-C (Rome III) as defined below and have rectal hypersensitivity (see below).

  • Patients must report recurrent abdominal pain or discomfort for at least 3 days per month in the last 3 months with two or more of the following symptoms:

    • Improvement with defecation; and/or
    • Onset associated with a change in frequency of stool; and/or
    • Onset associated with a change in form (appearance) of stool
  • No structural diseases
  • On a diary:

    • Pain/discomfort for at least 2 days/week;
    • No loose or watery stool <25% of bowel movements.

Exclusion Criteria:

  • Patients with mixed-IBS.
  • Patients currently on SSRI or MAO inhibitors. Patients on stable doses of other antidepressants will be included provided the dose is unchanged during study.
  • Patients taking drugs that are constipating, (e.g.; calcium channel antagonists will either be excluded or drug discontinued)
  • Patients with co-morbid illnesses; severe cardiac disease, chronic renal failure or previous gastrointestinal surgery except cholecystectomy and appendectomy.
  • Neurologic diseases e.g.; head injury, epilepsy, multiple sclerosis, strokes, spinal cord injuries.
  • Impaired cognizance (mini mental score of < 15) and/or legally blind.
  • Pregnant or likely to conceive during the course of the study. Women with potential for pregnancy must be willing to use contraceptive measures during the study. Urinary pregnancy tests will be performed on such women prior to any radiologic procedures.
  • Hirschsprung's disease.
  • Alternating constipation and diarrhea (22).
  • Ulcerative/Crohns colitis.
  • Previous pelvic surgery, rectocele/bladder repair, radical hysterectomy, anal surgery.
  • Rectal prolapse or anal fissure.
Both
18 Years and older
No
Contact: Satish SC Rao, MD, PhD 319-353-6602 satish-rao@uiowa.edu
United States
 
NCT00584571
2R01 KD57100-05A2, 2R01 KD57100-05A2
No
Satish SC Rao/Professor of Medicine Director, Neurogastroenterology & GI Motility, University of Iowa
University of Iowa
Not Provided
Principal Investigator: Satish SC Rao, MD, PhD University of Iowa
University of Iowa
February 2011

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