360° Coverage : Paid Constipation Clinical Trial Now Enrolling at Achieve...

Paid Constipation Clinical Trial Now Enrolling at Achieve Clinical Research in Birmingham, AL; Accepting M/F Patients with Opioid-Induced Constipation Age 18-80

Achieve Clinical Research is conducting a randomized clinical study to evaluate the safety, tolerability, and efficacy of a new drug for the treatment of opioid-induced constipation in adults taking opioid therapy for chronic non-cancer pain.

Aug 31 2013, 3:08am CDT | by PR.com

Birmingham, AL, August 31, 2013 --(PR.com)-- *To see if you qualify for this Constipation Clinical Trial in Alabama, visit Achieve Clinical Research on the web (http://www.achieveclinical.com) or contact us directly at (205) 380-6434. There is no cost to participate, no insurance is required, and you may receive compensation for time and travel.

Study Design
This is a multicenter, double-blind, placebo-controlled, parallel-group study in participants with opioid-induced constipation who are taking opioid therapy for chronic non-cancer pain. Participants will be randomized in a 1:1 ratio to receive the new constipation drug or matching placebo. The study will consist of 3 periods: a screening period of up to 21 days, a 52-week double-blind treatment period, and a 4-week follow-up period.

Background & Rational
Patients who take opioids often suffer from constipation and associated gastrointestinal side effects (e.g., abdominal cramping, abdominal bloating, excess gas) for as long as they remain on opioid therapy. Based on the reported literature and previous clinical trials, these patients often suffer from constipation for many years thus requiring long-term management for this condition.

Opioid-induced constipation has a negative impact on a patient’s quality of life and, if not treated effectively, can lead to serious complications including obstipation and bowel perforation. Moreover, patients may discontinue opioids because of the associated constipation, thereby compromising their pain management and increasing the risk of systemic opioid withdrawal.

No drug has been approved as monotherapy for the treatment of constipation in patients taking opioid therapy for chronic non-cancer pain. Current treatment options are limited: they include stool softeners and laxatives; diet and exercise; and opioid dose-reduction, switching, or discontinuation. However, these treatments are often ineffective, associated with significant GI side effects, and burdensome to patients.

Primary Objective
Evaluate the safety and tolerability of this experimental constipation drug in human participants over 12 months, relative to a placebo.

Inclusion Criteria
To be eligible for enrollment, a subject must meet all of the following criteria before any study-related procedures are conducted:

Is able to understand and comply with the study procedures and voluntarily provide written informed consent
Is a man or woman aged 18 to 80 years, inclusive, at the time of Screening
Has a body weight of ≥ 45 kg and a body mass index (BMI) ≤ 45 kg/m
Has not achieved adequate relief with other treatments for constipation (e.g., laxatives)
Is taking a stable daily dose of opioids of ≥ 30-mg morphine-equivalent total daily dose (METDD) for chronic non-cancer pain for ≥ 30 days before Screening and expected to continue on a dose of ≥ 30-mg METDD for the duration of the study
Is taking opioids via oral, transmucosal, sublingual, or transdermal routes of administration (intrathecal opioids via pump are permitted provided they are taken in addition to a full opioid agonist meeting the METDD requirement)
Has constipation that is caused by the chronic use of opioids and has the following self-reported symptoms of constipation that a) have occurred in temporal association with and directly related to starting opioid therapy, b) have persisted since starting opioid therapy, and c) have been present for ≥ 2 months:

-- Decreased BM frequency and
≥ 1 other BM symptom (i.e., straining to pass a stool, lumpy hard stools or small pellets, or sense of incomplete evacuation after passing a stool)

If female, subjects must not be pregnant (confirmed via pregnancy test at Screening and Day 1), and must meet either Criterion (a) or Criterion (b) below:

Is not of childbearing potential: defined as postmenopausal (i.e., having no menses for ≥ 1 year without an alternative medical cause) or surgically sterile because of bilateral tubal ligation, bilateral oophorectomy, or hysterectomy
Is of childbearing potential, meets 1 of the following 4 criteria:
Is abstaining from sexual intercourse
Is using an insertable, injectable, transdermal, or combination oral contraceptive for ≥ 1 cycle before randomization through 30 days after the subject’s last dose of study medication
Is practicing a double-barrier method of birth control (if composed of a spermicide with either a condom or diaphragm)
Has a vasectomized partner (and is using a spermicide, condom, or diaphragm)

*Achieve Clinical Research conducts Phase II-IV Clinical Trials in Alabama. For more information about participating in a Constipation Clinical Study, please visit our website or contact us directly at (205) 380-6434.

Contact Information:
Achieve Clinical Research
Lashondra Cade
(205) 380-6434 320
Contact via Email
www.achieveclinical.com

Read the full story here: http://www.pr.com/press-release/513110

Press Release Distributed by PR.com

Source: PR.com

 
 
 

blog comments powered by Disqus

Latest stories

Russia allows buffalo meat imports from India
Moscow, Dec 4 (IANS/TASS) Russia has allowed imports of buffalo meat from India, the country's veterinary regulator said Thursday.
 
 
New guidelines for prostate cancer testing
Melbourne, Dec 4 (IANS) Prostate cancer checks in Australia are set to improve after cancer agencies and health experts reached an agreement on new testing guidelines at the World Cancer Congress (WCC) currently being held in Melbourne.
 
 
Australian researcher discovers first artwork by early human
Sydney, Dec 4 (IANS) An Australian researcher has discovered what is believed to be the first artwork created by a human.
 
 
Insects compete with rats to clear garbage
New York, Dec 4 (IANS) Insects play a very important role in cleaning up cities and they compete with other pests like rats and pigeons in their endeavour, a study has said.
 
 
 

Latest from the Network

Australian researcher discovers first artwork by early human
Sydney, Dec 4 (IANS) An Australian researcher has discovered what is believed to be the first artwork created by a human. The simple zigzag pattern found on a fossilized shell from the Indonesian island of Java has...
Read more on Celebrity Balla
 
Insects compete with rats to clear garbage
New York, Dec 4 (IANS) Insects play a very important role in cleaning up cities and they compete with other pests like rats and pigeons in their endeavour, a study has said. Scientists sampled arthropods - such as...
Read more on Business Balla
 
School headmaster shot dead in Pakistan
Islamabad, Dec 4 (IANS) Unidentified gunmen Thursday killed the headmaster of a private school in Pakistan's Balochistan province. Police officials said the armed men opened fire at the vehicle of Zahid Ali,...
Read more on Politics Balla
 
Four more bodies recovered from sunken South Korean ship
Seoul, Dec 4 (IANS) Four more bodies were recovered Thursday from a sunken South Korean fishing ship in the Bering Sea, the foreign ministry here said. This increased the toll to 16, including six South Koreans and 10...
Read more on Politics Balla
 
Lesbian couple asked to desist in London restaurant
London, Dec 4 (IANS) A lesbian couple in a London restaurant was asked to desist by a staff member, who asked them to "stop what you are doing". Lydia Cawson, 29, said that she and her girlfriend were asked by a staff...
Read more on Politics Balla
 
Oxford Dictionaries to add 1,000 new words
London, Dec 4 (IANS) 'Mamil' (middle-aged man in Lycra), 'silvertail' (a person who is socially prominent or who displays social aspirations) and 'crony capitalism' are among the 1,000 new words to be added to...
Read more on Celebrity Balla
 
Oceans play key role in global 'warming hiatus'
London, Dec 4 (IANS) Increased heat uptake across three oceans - North Atlantic, the Southern Ocean and Equatorial Pacific Ocean - is the likely cause of the 'warming hiatus' -- the current decade-long slowdown in...
Read more on Politics Balla
 
Novel imaging to identify if TB drugs are working
Washington, Dec 4 (IANS) Tuberculosis patients who are not cured of the infection can develop multi-drug resistant TB and have to take as many as six drugs for two years. Now, researchers at University of Pittsburgh...
Read more on Business Balla
 
PM makes first appointment to High Court of Australia
Canberra, Dec 4 (IANS) Prime Minister Tony Abbott's government Thursday appointed former Victorian Supreme Court judge Geoffrey Nettle as the next Justice of the High Court of Australia. Attorney General George...
Read more on Politics Balla
 
18 suspected militants killed in Pakistan airstrikes
Islamabad, Dec 4 (IANS) At least 18 suspected militants were killed Thursday in airstrikes conducted by Pakistan Air Force fighter jets in North Waziristan. According to officials, the airstrikes were conducted in...
Read more on Politics Balla