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

History of Changes

Purpose

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.

Condition	Intervention	Phase
Rectal Hypersensitivity Irritable Bowel Syndrome-Constipation	Procedure: Sensory Adaptation Training with Barostat Drug: Escitalopram Therapy	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Allergy Constipation

Drug Information available for: Citalopram hydrobromide Citalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by University of Iowa:

Primary Outcome Measures:

Rectal Sensory Thresholds [ Time Frame: Trial entry and at the end of 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Global Symptom Assessment (GSA) of abdominal discomfort/pain [ Time Frame: Trial entry and at the end of 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	December 2007
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Sensory Adaptation	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
Experimental: Escitalopram Therapy	Drug: Escitalopram Therapy Escitalopram; 10 mg every day, orally. Other Name: Lexapro (Escitalopram) therapy

Arms

Assigned Interventions

Active Comparator: Sensory Adaptation

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

Experimental: Escitalopram Therapy

Drug: Escitalopram Therapy

Escitalopram; 10 mg every day, orally.

Other Name: Lexapro (Escitalopram) therapy

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00584571

Contacts

Contact: Satish SC Rao, MD, PhD

319-353-6602

satish-rao@uiowa.edu

Locations

United States, Iowa
University of Iowa Hospitals and Clinics	Recruiting
Iowa City, Iowa, United States, 52242

Sponsors and Collaborators

University of Iowa

Investigators

Principal Investigator:

Satish SC Rao, MD, PhD

University of Iowa

More Information

No publications provided

Responsible Party:	Satish SC Rao/Professor of Medicine Director, Neurogastroenterology & GI Motility, University of Iowa
ClinicalTrials.gov Identifier:	NCT00584571 History of Changes
Other Study ID Numbers:	2R01 KD57100-05A2, 2R01 KD57100-05A2
Study First Received:	December 21, 2007
Last Updated:	February 18, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Constipation
Hypersensitivity
Irritable Bowel Syndrome
Signs and Symptoms, Digestive
Signs and Symptoms
Immune System Diseases
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents

Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 16, 2013

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