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Rectal HypersensitivityPhase 2NCT00584571

SAT vs Escitalopram for Rectal Hypersensitivity

A Phase 2 study testing Sensory Adaptation Training and Escitalopram Therapy in people with Rectal Hypersensitivity and Irritable Bowel Syndrome-Constipation, run by Augusta University at 2 sites in United States.

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

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Sensory Adaptation Training and Escitalopram Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
2 sitesUnited States
Study dates
Dec 2007to 31 Dec 2019
Phase
Phase 2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Augusta University

    Augusta, Georgia, 30912

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

Other trials in United States

About this study

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

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.

Read the detailed description

To investigate a novel biofeedback technique of improving rectal hypersensitivity using rectal barostat and to compare this with clinical standard of care comprising of low dose antidepressant therapy with escitalopram. Patients will be randomized to sensory adaptation training or escitalopram in a 1:1 ratio

Being tested
Sensory Adaptation Training, Escitalopram Therapy

What participants receive

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

  • Sensory Adaptation TrainingProcedure or surgery

    Also called Barostat procedure

    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.

  • Escitalopram TherapyDrug

    Also called Lexapro (Escitalopram) therapy

    Escitalopram; 10 mg every day, orally.

Study groups in NCT00584571
Study groupRoleWhat they receive
Sensory Adaptation trainingActive comparatora large compliant balloon is placed in the rectum attached to a barostat. The balloon is distended in 1 mm increments until patient reports moderate discomfort and then increased in 1 mm increments until maximum tolerable pressure. Gradually over 6 training sessions, administered biweekly, the maximum tolerable pressure is increased over 3 months, if treatment is successful.
Receives: Procedure: Sensory Adaptation Training
Escitalopram TherapyExperimentalPatients randomized to this arm will receive daily 10 mg escitalopram for 3 months. If the medication is effective their bowel symptoms and pain thersholds will improve.
Receives: Drug: Escitalopram Therapy

What is being measured

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

  1. Rectal Sensory Thresholds

    The primary physiologic outcome measure is increase in rectal sensory thresholds after treatment. A rectal hypersensitivity responder is defined as an individual who show at least 20% increase in two or more sensory thresholds (first, desire and urge defecate/pain) after treatment when compared to baseline, and will be compared between the SAT and escitalopram groups. An overall responder is defined as both a hypersensitivity responder and abdominal pain responder.

    Measured: Trial entry and at the end of 3 months

  2. Abdominal Pain

    The symptomatic outcome measure is decrease in pain score as assessed by daily pain logs where pain is scored on a scale of 0 to 4, after treatment when compared to the baseline period. A pain responder is defined as a subject with 30% decrease in pain compared to baseline.

    Measured: Trial entry and at the end of 3 months

Secondary outcomes (5)

  1. Global Bowel Satisfaction Score (GSA)

    The global bowel satisfaction will be analysed using a visual analog scale 0-10 cm (0 - very dissatisfied, 10 - completely satisfied).

    Measured: Trial entry and at the end of 3 months

  2. Bowel symptoms

    We will assess the number of complete spontaneous bowel movements, mean straining scores, mean stool consistency (Bristol Stool Scale) (numerical mean scores for individual questions) between the two groups.

    Measured: Trial entry and at the end of 3 months

  3. Rectal compliance

    We will assess the changes in intrarectal pressures and intrarectal volumes during Barostat rectal balloon distention between the two groups.

    Measured: Trial entry and at the end of 3 months

  4. IBS quality of life

    The IBS quality of life will be assessed using the 8 domains of IBS-QOL and compared between the two groups.

    Measured: Trial entry and at the end of 3 months

  5. Psychological profiles

    The psychological profiles will be assessed using the SCL-90R questionnaire and compared between the two groups.

    Measured: Trial entry and at the end of 3 months

Timeline

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

  1. First posted2 Jan 2008 (estimated)
  2. Study startDec 2007
  3. Primary completion31 Dec 2015
  4. Study completion31 Dec 2019

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00584571
Sponsor's protocol ID
2R01 KD57100-05A2
Other IDs
2R01DK057100-06A2
Status last verified
Aug 2020
First submitted
21 Dec 2007
Last updated
6 Aug 2020
Results posted
No
Data monitoring committee
No

Publications

  • Rao SSC, Coss-Adame E, Yan Y, Erdogan A, Valestin J, Ayyala DN. Sensory Adaptation Training or Escitalopram for IBS With Constipation and Rectal Hypersensitivity: A Randomized Controlled Trial. Clin Transl Gastroenterol. 2021 Jul 13;12(7):e00381. doi: 10.14309/ctg.0000000000000381.

    PubMed 34254966

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sensory Adaptation Training and Escitalopram Therapy in people with Rectal Hypersensitivity and Irritable Bowel Syndrome-Constipation, run by Augusta University at 2 sites in United States.

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 9 inclusion and 12 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 6 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Rectal Sensory Thresholds (time frame: Trial entry and at the end of 3 months). The study lists 2 primary outcomes in all. 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 NCT00584571, which also lists 1 linked publication.

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 6 Aug 2020.

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