Investigation of Efficacy and Safety of PPC-5650 to Experimental Induced Sensation and Pain in the Rectosigmoid

NCT01449487 | Completed Phase 1 DMC

• 1 other identifier: Aros-001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Irritable Bowel Syndrome (IBS) is a gastrointestinal disorder characterized by chronic abdominal pain and altered bowel habits in the absence of any organic cause. Patients with IBS visit the doctor more frequently, use more diagnostic tests, consume more medications, miss more workdays, and consume more overall direct costs than patients without IBS. More specific treatment of the localized symptoms of IBS is therefore needed, why the present study will investigate the effect and mechanisms of PPC-5650. PPC-5650 is a new chemical entity that can negatively modulate the activity of Acid sensing ion channels (ASICs). It is a potent low molecular weight inhibitor for this class of ion channels described to date. It is hypothesized that safety, efficacy and mechanisms of local administration in the rectum of PPC-5650 can be evaluated by use of experimental induced sensation and pain in the rectum.

Conditions

Pain

Keywords

Experimental pain; IBS; Rectum

Outcome Measures

Primary Outcomes (1)

• Effect of PPC-5650

  Outcome measurements are achieved by use of multimodal pain responses (thermal, mechanical, electrical) in the rectosigmoid.

  Change in pain from baseline to 120 minutes

Secondary Outcomes (4)

• Safety profile of PPC-5650

  Change from baseline to 120 minutes

• Effect of PPC-5650

  Change in pain from baseline to 120 minutes

• Central mechanisms

  Change from baseline to 120 minutes

• Objective pain

  Change from baseline to 120 minutes

Study Arms (2)

PPC-5650

ACTIVE COMPARATOR

Drug: PPC-5650

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

PPC-5650 DRUG

Solution for administration in the rectum Single dose of 25µg/ml at a volume of 50ml

Also known as: No other name

PPC-5650

Placebo DRUG

Solution for administration in the rectum Identical tp active solution but without active drug

Also known as: No other name

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Postmenopausal women or women who have undergone hysterectomy, and males between 18 and 70 years of age
• Pain intensity during pain attack should be \>5 on the GSRS questionnaire
• Hypersensitivity within the last 2 years measured with the barostat
• Patients able to co-operate and tolerate the experimental procedures (as assessed in the training visit)
• Patients on stable medication
• Only patients that do not take over the counter medication 24h before the two study sessions

You may not qualify if:

• Any history of, or current condition or medication that, as judged by the investigator, may affect gastrointestinal function and the interpretation of the clinical data
• Any clinically relevant abnormal values from the laboratory tests on hematology, clinical chemistry, urine analyses and/or faeces testing, as judged by the investigator.
• Chronic extraintestinal pain dominating the clinical history
• Any known biochemical or structural abnormality of the digestive tract such as gluten enteropathy, bile acid diarrhea, lymphocytic colitis and/or collagenous colitis, Chronic inflammatory bowel diseases, chronic pancreatitis
• Major intra-abdominal surgery; appendectomy and minor laparoscopic gynecological surgery acceptable.
• Any planned surgical intervention within the duration of the trial.
• Any abdominal surgery
• Participation in any other clinical trial within three months prior to the pre-screening visit.
• Alcohol or drug abuse.

Sponsors & Collaborators

• Aros Pharma ApS: lead

Study Sites (1)

Department of Gastroenterology

Gothenburg, SE-413 45, Sweden

Location

Related Links

• Information regarding multi-modal probe used for inducing experimental pain in the rectum

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Asbjørn M Drewes, Professor

  Mech-Sense, Aalborg Hospital, Aalborg, Denmark

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2011
• First Posted: October 10, 2011
• Study Start: January 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 21, 2014

Record last verified: 2014-05

Locations

SE (1)